AU TGA Sponsor Services
Compare Australian TGA Sponsor providers. Request quotes, review onboarding requirements, and choose a partner for Australian market entry support.
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Avg. response time
500+
RFQs this month
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Compare AU TGA Sponsor Services Providers
For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.
KD&A Pty Ltd
KD&A Pty Ltd is a regulatory consultancy specializing in medical devices and IVDs for the Australian market. They offer expert guidance on TGA compliance, ARTG inclusions, and act as Australian TGA sponsors for overseas manufacturers.
KD&A Pty Ltd is a specialized regulatory consultancy firm focused on medical devices and In Vitro Diagnostic (IVD) devices. They provide expert guidance and services to manufacturers, sponsors, and distributors navigating the complexities of the Australian Therapeutic Goods Administration (TGA) regulatory framework. Their core services include assisting with TGA Conformity Assessment, CE Marking, and ensuring ARTG inclusions. KD&A is particularly adept at supporting overseas manufacturers by acting as their Australian TGA sponsor and providing essential regulatory support, including establishing an Australian address for devices. The firm stays abreast of evolving TGA regulations, including changes to Essential Principles, IVD classification, and Unique Device Identification (UDI) systems. They offer comprehensive support for developing Technical File Documentation, implementing Quality Management Systems (ISO 13485/MDSAP), and managing post-market surveillance. KD&A aims to help clients achieve regulatory success efficiently, enabling them to launch products and access new markets with confidence. Their expertise covers a wide range of regulatory requirements, from initial device classification and strategy to ongoing compliance and TGA annual invoicing management.
Website:
kdas.com.au
HQ:
Sydney, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
48 hours
Onboarding time:
5–30 days
Pricing model:
Retainer
Starting from:
AUD 3,500
Device Classes:
IVD
TGA Establishment:
Australian Sponsors & Distributors
Services:
ARTG Registration, Recall/Vigilance
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CMC Medical Devices Pty Ltd
CMC Medical Devices Pty Ltd is a global regulatory consulting firm specializing in medical devices and in vitro diagnostics. They offer in-country representation and consulting services to help manufacturers achieve regulatory compliance and market access worldwide.
CMC Medical Devices Pty Ltd is a specialized global regulatory consulting firm focused on medical devices and in vitro diagnostics (IVDs). With a strong presence and offices in key regions including Spain, the UK, Switzerland, China, Australia, and the USA, CMC provides comprehensive in-country representation and consulting services. Their expertise enables medical device manufacturers to navigate complex regulatory landscapes, achieve compliance, and gain market access in various international markets. They offer a range of services including acting as a TGA Sponsor in Australia, EU Authorized Representative (EC REP), and FDA Agent. CMC Medical Devices is committed to providing personalized solutions that address the specific needs of manufacturers, ensuring efficient and satisfactory outcomes. Their professional technical teams are dedicated to facilitating regulatory compliance and post-market surveillance, making them a reliable partner for global expansion.
Website:
cmcmedicaldevices.com
HQ:
Malaga, Spain
Jurisdictions:
AU
Countries:
AU
Languages:
English, French, Spanish
Response SLA:
24 hours
Onboarding time:
10–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
AUD 6,000
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
CMC Medical Devices PTY LTD
Services:
ARTG Registration, Recall/Vigilance
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Abdera Business Services
Abdera Business Services offers expert TGA sponsorship and company setup services for businesses looking to enter the Australian market. They provide comprehensive support for regulatory compliance and business expansion.
Abdera Business Services specializes in assisting overseas businesses with establishing a presence and navigating regulatory requirements in Australia. They offer crucial TGA sponsorship services, acting as a domestic legal entity responsible for ensuring therapeutic goods, including medicines and medical devices, comply with Australian standards and are registered on the ARTG. With extensive experience in the health and medtech sectors, Abdera streamlines the complex TGA approval process, allowing clients to focus on their core business strategies, clinical trials, and distribution. Their services extend to company setup, obtaining Australian Company Numbers (ACN) and Australian Business Numbers (ABN), and even providing a resident director for TGA sponsorship purposes. Beyond regulatory compliance, Abdera provides a suite of business support services, including accounting, virtual CFO, payroll, and HR, to facilitate seamless business operations and growth in Australia. They are committed to being a trusted partner, ensuring clients meet all legal and regulatory obligations while expanding their market reach.
Website:
abdera.com.au
HQ:
Sydney, Australia
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
72 hours
Onboarding time:
5–30 days
Pricing model:
Retainer
Starting from:
AUD 4,000
TGA Establishment:
NSW
Services:
ARTG Registration
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Regulatory Services Australia (RSA)
Regulatory Services Australia (RSA) is an AICIS, APVMA, and TGA registered agent and Medsafe New Zealand sponsor. They offer business and distribution services to help companies operate in Australia and New Zealand.
Regulatory Services Australia (RSA), operating as The Weringa Group Pty Ltd, is a specialized agency facilitating market entry and operations within Australia and New Zealand. They are officially recognized as an AICIS Agent, an APVMA Nominated Agent, and a TGA Sponsor, demonstrating their expertise in navigating regulatory landscapes. Additionally, RSA serves as a Medsafe New Zealand sponsor, further broadening their scope of services. RSA provides comprehensive business and distribution services, leveraging long-standing relationships with government agencies in Australia and overseas. Their team is equipped to assist clients with various aspects of market access, ensuring compliance and efficient operations. The company also highlights its extensive partner network, which can be a valuable asset for businesses seeking to establish or expand their presence in these regions. With offices in Sydney, Australia, and Auckland, New Zealand, RSA offers localized support and expertise. Their commitment is to help clients successfully do business in these key markets, backed by a professional team and a deep understanding of the regulatory environments.
Website:
regservices.au
HQ:
Sydney, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
48 hours
Onboarding time:
3–30 days
Pricing model:
Custom pricing
Starting from:
AUD 2,500
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
NSW
Services:
ARTG Registration, Recall/Vigilance
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DTS Regulatory Consultants
DTS is a Service-Disabled Veteran-Owned Small Business (SDVOSB) specializing in federal-ready cybersecurity and CMMC compliance for government contractors. They offer tailored solutions for secure, compliant, and operational readiness.
DTS Regulatory Consultants is a Service-Disabled Veteran-Owned Small Business (SDVOSB) founded in 2011, dedicated to providing federal-ready cybersecurity and CMMC compliance solutions. With over a decade of experience supporting federal agencies and the Defense Industrial Base, DTS combines cybersecurity authority with contracting credibility. They offer a comprehensive suite of services including GAP Analysis, Remediation, MSSP Services, Compliance Support, and Federal Services, ensuring clients achieve secure, compliant, and operational readiness. DTS is recognized for its proven outcomes, validated by C3PAO and DIBCAC assessors, and provides customized compliance solutions tailored to client environments. Their leadership team brings extensive military service, cybersecurity expertise, and federal contracting experience, operating with a mission-first mindset. DTS holds enterprise-level CMMC Level 2 certification and ISO 27001 ISMS certification, demonstrating their commitment to the highest security and compliance standards. They are a trusted partner for businesses and agencies seeking to navigate complex federal requirements and strengthen their security posture.
Website:
dtsreg.com.au
HQ:
ARLINGTON, US
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
24 hours
Onboarding time:
5–30 days
Pricing model:
Per project
Starting from:
AUD 5,000
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
Queensland
Services:
ARTG Registration, Recall/Vigilance
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RGN Medical
RGN Medical is a provider within the tga_sponsor_au directory, offering services related to the Military Health System (MHS). They are associated with the U.S. Department of Defense's health initiatives.
RGN Medical is listed as a provider within the tga_sponsor_au directory. The organization is associated with the U.S. Department of Defense's Military Health System (MHS), a large and complex healthcare institution responsible for providing health services to uniformed service members, military retirees, and their families. The MHS operates through both direct care at military hospitals and clinics, and private sector care. Its mission is to enable the Department of Defense to provide medically ready and ready medical forces by improving the health of all those entrusted to its care. The MHS aims to be a world role model for integrated military health and readiness, delivering technology-enabled, innovative, and military service-focused care. The website evidence indicates a strong connection to official U.S. government health information, specifically the health.mil domain, which is an official website of the United States government. This suggests RGN Medical's operations or focus align with the MHS's objectives and service delivery.
Website:
rgnmedical.com.au
HQ:
Adelaide, US
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
48 hours
Onboarding time:
10–14 days
Pricing model:
Retainer
Starting from:
AUD 3,000
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
AU
Services:
ARTG Registration, Recall/Vigilance
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EasiMed Pty Ltd
EasiMed Pty Ltd is an Australian TGA Sponsor and a leading supplier and service provider of medical, dental, and veterinary equipment in Adelaide, South Australia. They offer comprehensive services including sales, installation, after-sales support, maintenance, calibration, and repair.
EasiMed Pty Ltd, based in Adelaide, South Australia, serves as a crucial Australian TGA Sponsor, facilitating the entry of medical devices into the Australian market for overseas manufacturers. They provide essential regulatory support, ensuring compliance with Therapeutic Goods Administration requirements. As a direct supplier of medical, dental, and veterinary equipment, EasiMed is committed to sourcing the best products and offering competitive pricing. Their services extend beyond sales to include hands-on installation, setup, after-sales support, and ongoing maintenance. They specialize in autoclave steriliser services, medical equipment servicing, and surgical instrument repairs, including endoscopes. EasiMed's expertise also encompasses preventive maintenance, medical equipment service contracts, and accreditation testing in accordance with Australian Standards. They offer quick response services for equipment breakdowns and repairs, ensuring minimal disruption to healthcare operations. Their team of professionally trained biomedical technicians provides high-standard biomedical engineering support, focusing on customer satisfaction and the longevity of medical equipment.
Website:
easimed.com.au
HQ:
Adelaide, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
24 hours
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
AUD 2,000
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
Victoria
Services:
ARTG Registration, Recall/Vigilance
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MedicalQMS Australia
MedicalQMS Australia is a leading provider of minimally invasive medical devices, dedicated to improving patient outcomes and supporting healthcare professionals worldwide. They offer a unique portfolio of innovative solutions across various clinical specialties.
MedicalQMS Australia, operating under the Cook Medical brand, is a significant player in the global medical technology landscape. Founded on the principle of invention and a commitment to improving lives, the company specializes in developing, manufacturing, and delivering a unique portfolio of minimally invasive medical devices. These devices are designed to provide healthcare professionals with the tools they need to enhance patient care and facilitate recovery. The company's history is rooted in innovation, starting as a home-based business in 1963 and evolving into a thriving global enterprise. MedicalQMS Australia serves nearly every area of the modern hospital, supporting approximately 60 clinical specialties. Their approach is customer-centric, emphasizing listening to healthcare professionals to identify unmet needs and developing innovative solutions through their Vascular and MedSurg clinical divisions. Driven by core values of quality, ethics, and service, MedicalQMS Australia is committed to advancing patient care. They operate with a strong sense of responsibility towards patients, customers, and communities, ensuring fair and honest partnerships. Their dedication to 'doing the right thing' underpins their operations and their continuous pursuit of excellence in the field of medical technology.
Website:
medicalqms.com.au
HQ:
Brisbane, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
48 hours
Onboarding time:
7–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
AUD 4,500
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
Sponsor
Services:
ARTG Registration, Recall/Vigilance
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HL Pharma Regulatory Services
HL Pharma offers comprehensive pharmaceutical services in Australia, including regulatory support, TGA registration, global sourcing, and temperature-controlled storage and distribution.
HL Pharma Regulatory Services is a specialized provider based in Melbourne, Australia, offering end-to-end solutions for the pharmaceutical industry. They facilitate TGA registration and sponsorship for both domestic and international companies, managing the entire process from dossier preparation to ongoing compliance. Their services extend to global sourcing of licensed and unlicensed medicines, including managing supply under the TGA Special Access Scheme (SAS) and other provisions for critical medical needs and shortages. HL Pharma also provides advanced temperature-controlled storage and cold-chain logistics, ensuring compliant handling of various pharmaceutical schedules and unregistered products. With a strong emphasis on quality, evidenced by their ISO 9001:2015 certification and adherence to GDP & GWP principles, HL Pharma acts as a trusted partner for healthcare providers, manufacturers, and sponsors. They manage complex supply chains, from import and warehousing to national distribution, ensuring products are safely and efficiently delivered throughout Australia and the APAC region.
Website:
hlpharma.com.au
HQ:
Melbourne, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
72 hours
Onboarding time:
10–14 days
Pricing model:
Retainer
Starting from:
AUD 5,500
TGA Establishment:
Victoria
Services:
Recall/Vigilance
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Adjutor (Regulatory Consulting Australia)
Adjutor provides expert regulatory consulting and commercialisation services for medicines and medical devices in Australia and globally. They specialize in navigating pathways like TGA provisional registration and the ACCESS Consortium.
The Adjutor Group, including Adjutor Healthcare Pty Ltd, offers comprehensive regulatory consulting and commercialisation services for medicines and medical devices. They are experts in guiding clients through complex regulatory landscapes, including Australia's TGA provisional registration pathway and international initiatives like the ACCESS Consortium. Their services span product development, regulatory affairs, market access, quality management, and clinical trial support. With a focus on accelerating patient access to new therapies, Adjutor provides tailored teams to support businesses at any stage of product development or lifecycle. They are adept at designing strategies for efficient market entry and ensuring effective commercialisation. Their global network allows for seamless international service delivery, helping clients meet their goals across various markets. Adjutor emphasizes a collaborative and responsive approach, working closely with clients to achieve successful outcomes. They are committed to providing high-quality, timely, and effective solutions, positioning themselves as a key partner for biopharmaceutical companies seeking to navigate global regulatory challenges and expand market reach.
Website:
adjutor.com.au
HQ:
Melbourne, Australia
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
24 hours
Onboarding time:
3–14 days
Pricing model:
Per project
Starting from:
AUD 4,800
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
Pty Ltd
Services:
ARTG Registration
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Elevate MedTech
Elevate MedTech offers expert regulatory consulting and technical documentation for medical devices and SaMD. They specialize in navigating complex global regulations, including TGA (Australia), to accelerate market approval.
Elevate MedTech provides specialized regulatory consulting and technical documentation services for medical device and SaMD companies aiming for global market access. They offer tailored support for compliance with regulations such as TGA (Australia), UKCA (UK), and Medsafe (New Zealand), from initial product classification and strategy development to the creation of audit-ready technical files and software documentation. Their services include defining regulatory pathways, conducting gap analyses against standards like ISO 13485, and preparing regulator-ready submissions. Elevate MedTech also acts as a local sponsor for TGA applications in Australia and provides in-country representation, streamlining communication with authorities and accelerating product entry into the market. With a focus on efficiency and compliance, they help clients manage updates, respond to authority feedback, and build internal regulatory know-how through workshops and training programs. Elevate MedTech is committed to helping businesses achieve full compliance and accelerate their market approval processes.
Website:
elevate-med.tech
HQ:
Sydney, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
24 hours
Onboarding time:
5–14 days
Pricing model:
Custom pricing
Starting from:
AUD 3,500
Services:
ARTG Registration
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Acrapack Regulatory Services (ACRA)
Acrapack Regulatory Services simplifies medical device and IVD registration in Australia and New Zealand. They act as your Australian sponsor, managing compliance and market entry.
Acrapack Regulatory Services specializes in guiding companies through the complex process of registering medical devices and In Vitro Diagnostics (IVDs) in Australia and New Zealand. As an experienced Australian sponsor, Acrapack ensures your product labeling and packaging meet regulatory requirements, confidently representing your company and maintaining your registrations. They offer comprehensive management of product registration compliance, quality system implementation, and expert regulatory guidance. Acrapack provides tailored solutions to help you achieve your market visions, whether locally or globally. Their services are designed for companies in the medical, life science, biotechnology, and healthcare industries seeking to navigate the Australian and New Zealand regulatory landscapes. Acrapack is dedicated to resolving your regulatory concerns and providing focused support to ensure successful market access. They understand the nuances of the Australian medical device and IVD market, offering peace of mind and efficient management of your compliance needs.
Website:
registermedicaldevice.com.au
HQ:
Gold Coast, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
72 hours
Onboarding time:
3–30 days
Pricing model:
Per project
Starting from:
AUD 1,800
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
AUSTRALIA
Services:
ARTG Registration
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Vicki Partridge Pty Ltd
Vicki Partridge Pty Ltd offers expert medical device regulatory consulting and compliance services in Australia. They specialize in navigating complex regulatory affairs for medical equipment.
Vicki Partridge Pty Ltd is a dedicated provider of medical device regulatory consulting services, specializing in Australian compliance. They assist businesses in navigating the intricate landscape of medical device regulations, ensuring adherence to TGA (Therapeutic Goods Administration) requirements. With a focus on medical compliance, their expertise extends to various aspects of regulatory affairs, helping clients achieve market access and maintain product integrity. They are a key resource for companies seeking to understand and implement the necessary procedures for medical devices within Australia. Their services are designed to support sponsors and manufacturers in managing their regulatory obligations effectively. Whether it's initial registration, ongoing compliance, or strategic regulatory advice, Vicki Partridge Pty Ltd provides tailored solutions to meet the specific needs of the medical device industry.
Website:
vickipartridge.com
HQ:
Sydney, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
72 hours
Onboarding time:
10–21 days
Pricing model:
Retainer
Starting from:
AUD 3,200
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OMC Medical
The Office of the Marijuana Commissioner (OMC) regulates Delaware's recreational marijuana industry, focusing on public health, safety, and tax revenue. They establish licensing, guidelines, and address complaints to ensure a regulated market.
The Office of the Marijuana Commissioner (OMC) is the state agency tasked with regulating Delaware's recreational marijuana industry, as established by the Delaware Marijuana Control Act effective July 5, 2023. The OMC's primary objectives include safeguarding public health, preventing underage usage, and generating tax revenue. They are committed to fostering an equitable and competitive market that prioritizes consumer welfare and public safety, with the ultimate goal of eradicating the illegal marijuana market. To achieve these goals, the OMC is responsible for developing comprehensive rules and guidelines, managing the licensing process for marijuana businesses, and handling complaints to ensure effective regulation of marijuana cultivation, manufacturing, and sales within the state. The agency also publishes annual reports detailing industry activities, sales data, and demographic statistics. The OMC operates under the Department of Safety and Homeland Security and is located at 1128 South Bradford Street, Dover, Delaware 19904. They can be contacted via email at omc@delaware.gov or by phone.
Website:
omc.delaware.gov
HQ:
Dover, US
Jurisdictions:
AU
Countries:
AU
Languages:
English, Chinese, Spanish
Response SLA:
24 hours
Onboarding time:
5–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
AUD 7,000
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PharmOut
PharmOut is a leading Australian consultancy firm specializing in medical device and pharmaceutical regulatory affairs, GMP compliance, and quality systems. They offer expert guidance for TGA submissions, audits, and manufacturing licenses.
Established in 2006, PharmOut has grown to become the region's largest medical device and pharmaceutical consultancy firm, headquartered in Melbourne, Australia. They provide a comprehensive range of services including GMP, medical device, and regulatory consulting to manufacturers and product distributors across the Asia Pacific region. PharmOut's expertise extends to assisting clients with TGA regulatory affairs, including TGA GMP audit response, ARTG registration, and obtaining manufacturing licenses for products like medicinal cannabis. They also offer support for APVMA GMP compliance for veterinary medicines and agricultural chemical products. Their team comprises experienced consultants, including former TGA inspectors, who help clients navigate complex regulatory landscapes, implement quality management systems (QMS), and achieve compliance with international standards such as ISO 13485, EU GMP, and US FDA GMP. PharmOut also provides services in facility design, validation, and contracting of QA and GMP professionals.
Website:
pharmout.net
HQ:
Melbourne, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
24 hours
Onboarding time:
5–30 days
Pricing model:
Per project
Starting from:
AUD 6,500
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
Melbourne, Australia
Services:
ARTG Registration, Recall/Vigilance
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Qualtech Consulting Corporation Pty Ltd
Qualtech Consulting Corporation offers expert regulatory consulting and clinical trial services for medical devices, specializing in market access and product registration across Asia and globally. With over 20 years of experience, they provide one-stop solutions for over 1,000 clients.
Founded in 2000, Qualtech Consulting Corporation is a leading regulatory consulting and clinical trial (CRO) company for medical devices. With over 20 years of experience and a global network, Qualtech specializes in helping medical device manufacturers gain market access, navigate product registration, and manage post-market activities. They offer comprehensive one-stop solutions, leveraging a cross-disciplinary team of professionals dedicated to integrity, diversity, and continuous learning. Qualtech has successfully assisted over 1,000 clients in achieving market access in various regions and has managed over 5,000 medical device licenses with precision. Their expertise includes Clinical Evaluation Report (CER) writing, crucial for entering markets like the EU and China. They are also adept at navigating specific regional regulations, such as updates from the Thai FDA and Malaysian MDA. With local representation in 12 markets worldwide, including China, Japan, Singapore, Malaysia, Philippines, Hong Kong, Indonesia, and Vietnam, Qualtech provides real-time services and support. They are committed to offering professional assistance without delay, assigning dedicated account managers backed by a strong tech center to ensure an efficient and enjoyable client journey. Their services encompass product registration, clinical services, and authorized representation, making them a trusted partner for medical device companies seeking to expand their business globally.
Website:
qualtechs.com
HQ:
Taipei, Taiwan
Jurisdictions:
AU
Countries:
AU
Languages:
English, Korean, Japanese, Chinese
Response SLA:
48 hours
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
AUD 8,000
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Freyr Solutions Australia
Freyr Solutions Australia is a leading regulatory consulting firm specializing in TGA submissions and market access for life sciences companies. They offer end-to-end support for medicinal products, medical devices, and food supplements.
Freyr Solutions Australia is a premier regulatory consulting firm dedicated to assisting life sciences companies navigate the complexities of the Australian market. With a strong focus on Therapeutic Goods Administration (TGA) regulations, they provide comprehensive services for product registration and market authorization. Their expertise spans medicinal products, medical devices, and food supplements, offering tailored solutions for each category. Freyr Australia helps clients with TGA eCTD submissions, regulatory strategy, market intelligence, in-country representation, and post-market surveillance functions. They also provide next-generation regulatory software solutions to streamline the entire TGA registration lifecycle. Leveraging their deep understanding of TGA requirements and extensive experience, Freyr Solutions Australia acts as a crucial partner for companies seeking to register and distribute their products in Australia. They ensure smooth review and approval processes, facilitating timely market entry and compliance with evolving regulations.
Website:
freyrsolutions.com.au
HQ:
Sydney, Australia
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
48 hours
Onboarding time:
7–30 days
Pricing model:
Retainer
Starting from:
AUD 9,000
Device Classes:
IVD
TGA Establishment:
Australia
Services:
ARTG Registration
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MedEnvoy Australia
MedEnvoy Australia is your dedicated partner for navigating Australian TGA regulations. We streamline medical device and IVD registration, ensuring compliance and market access.
MedEnvoy Australia specializes in providing expert TGA Sponsor services for medical device and IVD companies seeking to enter the Australian market. Based in Sydney, we facilitate the registration of your devices in the Australian Register of Therapeutic Goods (ARTG), ensuring compliance with TGA requirements. We understand that even devices with CE Marking or FDA clearance require separate TGA registration. Our team assists in navigating the TGA classification system, which closely mirrors the EU system but may have specific Australian rules. We help confirm device classification and ensure all necessary documentation, such as Manufacturer's Declarations and Technical Documentation, meets TGA standards. MedEnvoy Australia also supports manufacturers in understanding and complying with the Prescribed List (PL) requirements for private health insurer reimbursement. Our mission is to simplify regulatory complexities, allowing you to focus on innovation and commercialization while we ensure seamless market entry and ongoing compliance in Australia.
Website:
medenvoyglobal.com
HQ:
Sydney, AU
Jurisdictions:
AU
Countries:
AU
Languages:
English, German, French, Spanish
Response SLA:
48 hours
Onboarding time:
7–30 days
Pricing model:
Retainer
Starting from:
AUD 7,500
Device Classes:
IVD
TGA Establishment:
Sydney
Services:
ARTG Registration
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SUNGO Global Regulatory Services
SUNGO Global Regulatory Services is a trusted compliance service provider for the healthcare industry, specializing in international medical device registration and consulting.
Established in 2006, SUNGO Global Regulatory Services (SUNGO) is dedicated to facilitating the global circulation of health products and aims to be the most trusted compliance service agency. With its group headquarters in Shanghai, China, SUNGO has established international branches in Rotterdam, Netherlands; Düsseldorf, Germany; Zug, Switzerland; London, UK; Sydney, Australia; and Kentucky, USA. These branches offer local representation and device registration services to global manufacturers. Domestically, SUNGO has three subsidiaries in Wuhan, Guangzhou, and Hefei, providing localized technical support. The group boasts two medical device laboratories with China's national CMA qualification, also accredited by CNAS and IAS, and an ANAB-accredited medical device quality system certification body. This robust infrastructure enables SUNGO to deliver comprehensive compliance solutions. SUNGO's core services encompass international medical device registration (EU, UK, US, Australia, Canada, Saudi Arabia, Brazil, China), consulting (MDR, IVDR, 510k, NMPA GMP, QSMR820), and testing (sterilization validation, active device validation, rehabilitation device testing). They have served over 6,000 clients across more than 30 countries, including a significant portion of China's top 100 medical device companies and several global top 100 enterprises. SUNGO holds leading market shares in China for EU, US, UK, and Swiss registrations.
Website:
sungoglobal.com
HQ:
Shanghai, CN
Jurisdictions:
AU
Countries:
AU
Languages:
English, Chinese
Response SLA:
48 hours
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
AUD 5,000
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SGB Consulting Services (Australia Market Access)
SGB Consulting Services offers expert regulatory affairs and quality assurance support for medical devices and IVDs. They specialize in global market access, TGA Australia compliance, and navigating complex regulations like MDR and IVDR.
SGB Consulting Services, operating as SGB QA/RA Consulting Ltd, is a specialized consultancy focused on global market access and regulatory compliance for medical devices and In Vitro Diagnostic (IVD) products. With extensive experience, they assist clients in navigating the stringent requirements of regulatory bodies worldwide, including the Therapeutic Goods Administration (TGA) in Australia. Their expertise covers the entire lifecycle of medical devices, from initial development and Quality Management System (QMS) implementation to achieving compliance with international standards such as ISO 13485:2016 and ISO 27001:2022. They are adept at preparing technical documentation, managing risk, and ensuring devices meet the necessary criteria for market entry. SGB Consulting Services provides tailored support for Software as a Medical Device (SaMD) and helps clients achieve compliance in key markets including the UK, EU, and USA. They also offer guidance on post-Brexit solutions and UDI/EUDAMED compliance, ensuring businesses can successfully bring their innovative healthcare technologies to global consumers.
Website:
sgbconsultingservices.co.uk
HQ:
Bristol, United Kingdom
Jurisdictions:
AU
Countries:
AU
Languages:
English
Response SLA:
48 hours
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Starting from:
AUD 6,000
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
Services:
ARTG Registration
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EU Boost
EU Boost is an initiative by the European Commission to simplify digital rules, foster innovation, and support EU businesses in scaling and saving administrative costs.
EU Boost, a project by the European Commission, aims to streamline digital regulations across the EU. The initiative focuses on making compliance easier for businesses by simplifying rules related to data, cybersecurity, and AI. It is part of a broader 'Digital Package' designed to boost innovation and help EU companies scale their operations more effectively. This effort includes strategies like the Data Union Strategy and proposals for European Business Wallets, all contributing to a more agile and supportive digital environment for businesses within the European Union.
Website:
digital-strategy.ec.europa.eu
HQ:
EU
Languages:
English
Device Classes:
Class I, Class Is/Im/Ir
TGA Establishment:
FL
Services:
ARTG Registration, Recall/Vigilance
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GlobalCompliance Solutions Pro
Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.
Website:
globalcompliance-solutions.com
HQ:
Boston, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
New South Wales
Services:
ARTG Registration, Recall/Vigilance
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MedReg International Pro
Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.
Website:
medreg-international.com
HQ:
London, UK
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
New South Wales
Services:
ARTG Registration, Recall/Vigilance
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Regulatory Excellence Partners Pro
Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.
Website:
regulatoryexcellence.com
HQ:
San Francisco, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Device Classes:
Class I, Class Is/Im/Ir, Class IIa
TGA Establishment:
New South Wales
Services:
ARTG Registration, Recall/Vigilance
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Comprehensive Buyer's Guide
1. Who Needs a TGA Sponsor?
Overseas manufacturers placing medical devices on the Australian market must appoint an Australian-based TGA Sponsor.
This requirement applies to:
- Non-Australian medical device manufacturers supplying devices in Australia
- Overseas manufacturers entering the Australian market
- Manufacturers transitioning to Australian market entry
- Companies needing ARTG registration for their devices
Note: The TGA Sponsor must be established in Australia and assumes regulatory responsibility for the devices. The sponsor acts as the primary contact point for the TGA and is responsible for ARTG registration, adverse event reporting, and compliance.
2. What Services Are Typically Included?
TGA Sponsor services typically include:
- Regulatory sponsorship: Acting as your sponsor for TGA regulatory purposes
- ARTG registration: Supporting device registration on the Australian Register of Therapeutic Goods
- TGA communication: Serving as contact point with the TGA
- Adverse event reporting: Handling incident reporting and defect notifications
- Post-market surveillance: Supporting PMS activities and compliance monitoring
- Recall management: Supporting recalls and corrective actions if needed
- Compliance support: Ensuring ongoing compliance with TGA requirements
3. What Affects Pricing?
TGA Sponsor pricing varies based on:
- Device classification: Class III and higher risk devices typically cost more
- Portfolio size: Number of devices and device families
- Service scope: Basic sponsorship vs. comprehensive regulatory support
- Regulatory pathway: Complexity of ARTG registration requirements
- Surveillance needs: Post-market surveillance and adverse event reporting
- Contract terms: Annual retainer vs. per-device fees
4. How to Choose a Provider
Key factors to consider:
- Australian establishment: Verify they're established in Australia
- Device class experience: Confirm experience with your device classifications
- Regulatory expertise: Verify understanding of TGA requirements and ARTG processes
- Vigilance capabilities: Assess their incident reporting and adverse event handling
- Response times: Verify SLA for TGA communications and incident reporting
- Independence: Consider whether you prefer an independent sponsor vs. distributor-sponsor
- Additional services: Check if they offer ARTG registration support or broader consulting
Frequently Asked Questions
Q1: What does a TGA Sponsor do?
A TGA Sponsor is an Australian-based legal entity responsible for ensuring that medical devices comply with Australian regulatory requirements before they can be supplied in Australia. The sponsor acts as the primary contact point for the Therapeutic Goods Administration (TGA) and assumes regulatory responsibilities. Key responsibilities include: registering devices on the Australian Register of Therapeutic Goods (ARTG), ensuring devices meet TGA requirements for safety, quality, and performance, maintaining records about medical devices supplied, reporting adverse events and defects to the TGA (within 15 days of becoming aware), implementing corrective actions including recalls if necessary, ensuring proper labeling and advertising compliance, and liaising with the TGA on regulatory matters. The sponsor must be established in Australia and cannot be a foreign manufacturer—overseas manufacturers must appoint an Australian sponsor. The sponsor takes on significant regulatory responsibility and liability for the devices they sponsor.
Q2: Can a TGA Sponsor support multiple device families?
Yes, many TGA Sponsors support multiple device families and diverse portfolios. However, the sponsor's ability to effectively support multiple device families depends on: their expertise and experience with different device types and classifications, their operational capacity and resources, their understanding of different regulatory pathways (e.g., inclusion in ARTG, conformity assessment certificates, etc.), and their ability to manage diverse portfolios while maintaining compliance. When evaluating sponsors, confirm: their experience with your specific device types and classifications, their current portfolio size and diversity, their operational capacity to handle additional devices, and their track record with similar device families. Some sponsors specialize in specific device categories (e.g., IVD, active devices, implants), while others offer broad support across many device types. For complex portfolios with diverse device families, ensure the sponsor has the expertise and capacity to effectively manage all your devices.
Q3: What affects TGA Sponsor fees?
TGA Sponsor pricing varies based on several factors: device classification and risk (Class I, IIa, IIb, III, or IVD—higher risk classes typically cost more due to increased regulatory requirements), portfolio size (number of devices and device families), service scope (basic sponsorship vs. comprehensive regulatory support including ARTG registration, vigilance, PMS, etc.), regulatory pathway complexity (some devices require more complex registration processes), surveillance needs (post-market surveillance, adverse event reporting, recall management), change management (frequency of device changes requiring notifications), and contract terms (annual retainer vs. per-device fees, setup fees, etc.). Some sponsors also charge for: ARTG registration support, TGA application fees (which are separate from sponsor fees), ongoing compliance monitoring, and specific services like recall management. Request detailed pricing breakdowns to understand all costs. Sponsor fees can range from a few thousand AUD per year for simple Class I devices to tens of thousands for complex Class III portfolios.
Q4: What is needed to onboard with a TGA Sponsor?
To onboard with a TGA Sponsor, prepare: device information (device names, classifications, GMDN codes, intended use), technical documentation (summaries of technical files, evidence of safety and performance, conformity assessment certificates if applicable), labeling and IFU samples (Australian labeling requirements, instructions for use), quality management system information (ISO 13485 certificates, QMS overview), manufacturing information (manufacturing sites, quality controls), existing registrations (if devices were previously on market, ARTG numbers, etc.), and company details (manufacturer information, contact details, etc.). The sponsor may also request: risk management files, clinical evaluation summaries, post-market surveillance data, and any previous TGA correspondence. More complete documentation can speed up onboarding, typically 2-6 weeks for straightforward cases. The sponsor will review your documentation to assess regulatory requirements and provide a quote. Some sponsors offer pre-onboarding assessments to identify requirements early.
Q5: How do I compare TGA Sponsors effectively?
When comparing TGA Sponsors, evaluate: Australian establishment (verify they're established in Australia and can provide Australian address and contact details), device class experience (confirm experience with your specific device classifications, especially if you have Class III or complex devices), regulatory pathway expertise (understanding of different ARTG registration pathways, conformity assessment requirements), vigilance and PMS capabilities (incident reporting, adverse event management, recall support), response times (SLA for TGA communications, change notifications, incident reporting), additional services (some sponsors offer broader regulatory consulting, ARTG registration support, etc.), contract terms (flexibility, termination clauses, fee structures), and references (ask about their largest clients, track record, client testimonials). Also consider: whether they're independent (not also your distributor, which can create conflicts), their understanding of your industry and device types, and their ability to scale support as your portfolio grows. Some manufacturers prefer independent sponsors to maintain control, while others work with distributor-sponsors for convenience.
Q6: What is the difference between a TGA Sponsor and a distributor?
A TGA Sponsor is a regulatory role required for placing medical devices on the Australian market—the sponsor is responsible for regulatory compliance and acts as the TGA contact point. A distributor is a commercial role—a company that sells or supplies devices to end users. These are distinct roles, though a company can be both. Key differences: the sponsor has regulatory responsibilities (ARTG registration, adverse event reporting, compliance), while the distributor has commercial responsibilities (sales, marketing, customer relationships). The sponsor must be established in Australia, while distributors can be foreign entities. The sponsor assumes regulatory liability, while distributors have different liability structures. Many manufacturers prefer independent sponsors (not also their distributor) to maintain control over regulatory matters and avoid conflicts of interest. However, some manufacturers work with distributor-sponsors for convenience. When evaluating sponsors, consider whether independence is important for your situation.
Q7: How quickly can I get devices registered with a TGA Sponsor?
TGA registration timelines vary significantly based on several factors: device classification (Class I devices may be faster than Class III), regulatory pathway (some pathways are faster than others), completeness of documentation (more complete documentation speeds up the process), TGA processing times (which can vary), and sponsor's efficiency (some sponsors process applications faster than others). Typical timelines: Class I devices (self-assessed) can take 2-4 weeks for ARTG inclusion, Class IIa/IIb devices (with conformity assessment) can take 2-6 months, Class III devices can take 6-12 months or longer, and IVD devices vary by classification. The sponsor can provide more specific timelines based on your devices and regulatory pathway. Some sponsors offer expedited services for urgent cases, though this typically incurs additional fees. Early engagement with a sponsor can help identify requirements and plan the registration strategy, potentially reducing overall timelines.
Q8: Can I change my TGA Sponsor?
Yes, you can change your TGA Sponsor, but the process requires coordination with both the old and new sponsors, as well as notification to the TGA. The process involves: appointing a new sponsor before terminating the previous one (to ensure continuity), notifying the TGA of the sponsor change, updating ARTG registrations to reflect the new sponsor, transferring regulatory documentation and records to the new sponsor, and coordinating the transition to ensure no gaps in regulatory coverage. The new sponsor will need access to your technical documentation and must be able to assume regulatory responsibilities immediately. There's typically a transition period to ensure continuity. Some manufacturers change sponsors due to service issues, cost, strategic reasons, or if they need a sponsor with different expertise. Review contract terms regarding termination notice periods and any fees associated with changing sponsors. The TGA must be notified of sponsor changes, and ARTG registrations must be updated accordingly.
Provider Comparison Table
| Provider | Key Services | Languages | Response SLA | |
|---|---|---|---|---|
| KD&A Pty Ltd | AU | ARTG, Recall | English | 48h |
| CMC Medical Devices Pty Ltd | AU | ARTG, Recall | English, French | 24h |
| Abdera Business Services | AU | ARTG | English | 72h |
| Regulatory Services Australia (RSA) | AU | ARTG, Recall | English | 48h |
| DTS Regulatory Consultants | AU | ARTG, Recall | English | 24h |
| RGN Medical | AU | ARTG, Recall | English | 48h |
| EasiMed Pty Ltd | AU | ARTG, Recall | English | 24h |
| MedicalQMS Australia | AU | ARTG, Recall | English | 48h |
| HL Pharma Regulatory Services | AU | Recall | English | 72h |
| Adjutor (Regulatory Consulting Australia) | AU | ARTG | English | 24h |
Sources & Official Guidance
-
TGA — Medical device sponsors
Official TGA guidance for sponsor role in Australia.
Last Updated: 2026-02-04
Reviewed by: Cruxi Regulatory Affairs Team
