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.
About
**Who they are**
CMC Medical Devices Pty Ltd is a global regulatory consulting firm specializing in medical devices and in vitro diagnostics. They provide in-country representation and consulting services to assist manufacturers in achieving regulatory compliance and market access worldwide.
**Expertise & scope**
* **Global Representation:** Acts as authorized representatives and primary points of contact with local authorities in various regions, ensuring smooth communication and continuous regulatory compliance.
* **Key Markets Served:** Offers representation services in Europe (EU REP), the UK (UK REP), Switzerland (CH REP), Australia (TGA Sponsor), the USA (FDA Agent), and China (NMPA Agent).
* **Regulatory Support:** Assists with product registration, technical file preparation (e.g., for MDR and IVDR in the EU), and post-market compliance.
* **Ancillary Services:** Provides support for Free Sale Certificates (FSC), acts as a Clinical Research Organization (CRO), and offers consulting on regulations like ISO 13485 and EUDAMED registration.
**Reputation / proof points**
* Member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a subsidiary of CMC Group and a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH is located in Switzerland and cooperates with SWISSMEDIC.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC MEDICAL DEVICES LLC has extensive knowledge and experience in FDA regulations.
CMC Medical Devices Pty Ltd is a global regulatory consulting firm specializing in medical devices and in vitro diagnostics. They provide in-country representation and consulting services to assist manufacturers in achieving regulatory compliance and market access worldwide.
**Expertise & scope**
* **Global Representation:** Acts as authorized representatives and primary points of contact with local authorities in various regions, ensuring smooth communication and continuous regulatory compliance.
* **Key Markets Served:** Offers representation services in Europe (EU REP), the UK (UK REP), Switzerland (CH REP), Australia (TGA Sponsor), the USA (FDA Agent), and China (NMPA Agent).
* **Regulatory Support:** Assists with product registration, technical file preparation (e.g., for MDR and IVDR in the EU), and post-market compliance.
* **Ancillary Services:** Provides support for Free Sale Certificates (FSC), acts as a Clinical Research Organization (CRO), and offers consulting on regulations like ISO 13485 and EUDAMED registration.
**Reputation / proof points**
* Member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a subsidiary of CMC Group and a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH is located in Switzerland and cooperates with SWISSMEDIC.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC MEDICAL DEVICES LLC has extensive knowledge and experience in FDA regulations.
Additional information
CMC Medical Devices emphasizes its role as a crucial liaison between manufacturers and regulatory bodies. For instance, as a TGA Sponsor in Australia, they act as the regulatory representative for products, managing the registration process with the Therapeutic Goods Administration (TGA) as per the Therapeutic Goods Act 1989 and related regulations. Similarly, in the US, their FDA Agent services ensure smooth and compliant importation of devices. They highlight that the appointed representative is responsible for addressing inquiries from authorities and ensuring prompt responses, which is vital for maintaining market access and compliance.
Key Highlights
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Provides TGA Sponsor services for medical device and IVD registration in Australia.
Source
“We provide Sponsor services in Australia to ensure regulatory compliance and facilitate the entry of your products into the Australian market.”
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Offers EU Authorized Representative (EC REP) services for medical devices and IVDs under MDR and IVDR.
Source
“For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) require that manufacturers outside the EU designate an european authorized representative based within the EU.”
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Appoints a UK Responsible Person (UKRP) to ensure product compliance with British market regulations post-Brexit.
Source
“Since Brexit, manufacturers based outside the UK (including EU companies) are required to appoint a UK-based Responsible Person (UK RP) for their medical devices and in vitro diagnostic devices.”
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Facilitates market entry into China by acting as an Authorized Representative for NMPA registration.
Source
“We provide Representation services in China, facilitating the entry of your products into the Chinese market and ensuring compliance with local regulations.”
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Serves as a US FDA Agent for foreign manufacturers of medical devices and IVD products.
Source
“We offer FDA Agent services in the United States to ensure that your products comply with FDA requirements and can successfully enter the US market.”
Certifications & Trust Signals
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Member of the European Association of Authorized Representatives (E.A.A.R).
Source
“Spain is a member of the European Union (EU) and is within the European Economic Area (EEA). CMC Medical Devices & Drugs SL, located in Spain, is a member of the European Association of Authorized Representatives (E.A.A.R).”
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CMC Medical Devices UK is a subsidiary of CMC Group and a member of the Association of Responsible Persons in the UK.
Source
“CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom. As a member of the Association of Responsible Persons in the UK, it has a professional international regulatory team...”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking international market access.
- Companies requiring local representation in key global markets.
- Firms needing assistance with regulatory compliance and product registration.
How engagement typically works
- Acts as a direct point of contact with regulatory authorities.
- Provides ongoing support for compliance and market access.
- Offers consulting services to navigate complex regulations.
Typical deliverables
- Designated TGA Sponsor in Australia.
- Authorized Representative (EU REP, CH REP, China NMPA Agent).
- UK Responsible Person (UKRP).
- US FDA Agent services.
- Support with Free Sale Certificates and technical documentation.
Good to know
- Best when manufacturers are based outside the target market and require local representation.
HQ:
Malaga, Spain
Languages:
English, French, Spanish
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Hospital equipment, Consumables, Medical devices
Portfolio:
26-100
Onboarding time:
10–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
AUD 6,000
Included services:
Change notification and variation assessment, Sponsor address and labeling review, Conformity assessment evidence mapping (EU/UK/US/CA), ARTG inclusion application preparation and submission
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Australian Entity State:
CMC Medical Devices PTY LTD
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
Additional tga_sponsor_au Details
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports Artg
Yes
Recall Vigilance Support
Yes
Onboarding Steps
The process typically involves selecting CMC as the representative, after which a consultant will get in touch. For specific regions, they act as the primary point of contact with local authorities, assist in product registration, and handle inquiries from regulatory bodies.
