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.
About
**Who they are**
MedEnvoy Australia is a dedicated partner for navigating Australian TGA regulations, specializing in streamlining medical device and IVD registration to ensure compliance and market access. They are committed to empowering small and medium-sized companies in the health care and life sciences industry by providing consolidated services for local regulatory requirements in key international markets.
**Expertise & scope**
* In-Country Representative and Regulatory Importer services for medical devices and IVDs.
* Australian TGA Sponsor services, including ARTG registration for medical devices.
* Assistance with TGA application review and documentation review based on device classification.
* Expertise in navigating TGA classification systems, which closely align with EU classification.
* Leveraging approvals from other markets such as CE Marking and FDA clearance for TGA registration.
**Reputation / proof points**
* Established in the Netherlands by experienced regulatory affairs executives.
* Offices in Sydney, Australia, to provide local TGA Sponsor services.
MedEnvoy Australia is a dedicated partner for navigating Australian TGA regulations, specializing in streamlining medical device and IVD registration to ensure compliance and market access. They are committed to empowering small and medium-sized companies in the health care and life sciences industry by providing consolidated services for local regulatory requirements in key international markets.
**Expertise & scope**
* In-Country Representative and Regulatory Importer services for medical devices and IVDs.
* Australian TGA Sponsor services, including ARTG registration for medical devices.
* Assistance with TGA application review and documentation review based on device classification.
* Expertise in navigating TGA classification systems, which closely align with EU classification.
* Leveraging approvals from other markets such as CE Marking and FDA clearance for TGA registration.
**Reputation / proof points**
* Established in the Netherlands by experienced regulatory affairs executives.
* Offices in Sydney, Australia, to provide local TGA Sponsor services.
Additional information
MedEnvoy Australia assists manufacturers with the ARTG registration of their devices. While the TGA recognizes other markets' approvals like CE Marking and FDA clearance, these devices still require registration with the TGA. The TGA classification system is similar to the EU system, but MedEnvoy's role as an Australian TGA Sponsor includes confirming classification according to Australian rules, as some deviations may exist. They emphasize building customer relationships and using digital and AI technologies for efficient, high-quality solutions, enabling clients to focus on innovation and growth.
Key Highlights
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Offers Australian TGA Sponsor services for medical device and IVD registration.
Source
“MedEnvoy offers Australian TGA Sponsor services and assists manufacturers with the ARTG registration of their devices.”
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Streamlines medical device and IVD registration for Australian market access.
Source
“We streamline medical device and IVD registration, ensuring compliance and market access.”
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Assists with ARTG registration, even for devices with CE Marking or FDA clearance.
Source
“Yes, even if your device has CE Marking or FDA clearance, it still needs to be registered with the TGA.”
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Provides In-Country Representative and Regulatory Importer services.
Source
“Meet the leaders in medical device and IVD In-Country Representative and Regulatory Importer services.”
Certifications & Trust Signals
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Established in the Netherlands by experienced and reputable regulatory affairs executives.
Source
“Established in the Netherlands by experienced and reputable regulatory affairs executives, MedEnvoy”
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Committed to ensuring patients access safe and innovative healthcare products.
Source
“MedEnvoy is committed to ensuring that patients around the globe can access safe and innovative healthcare and life sciences products”
Buyer Snapshot
Best for
- Small and medium-sized health care and life sciences companies
- Manufacturers seeking TGA Sponsor services for medical devices and IVDs
How engagement typically works
- Partnership-focused approach
- Leveraging digital and AI technologies for efficiency
Typical deliverables
- ARTG registration for medical devices
- TGA Sponsor representation
- Regulatory compliance guidance for the Australian market
Good to know
- Best when requiring assistance with Australian TGA regulations and ARTG registration.
HQ:
Sydney, AU
Languages:
English, German, French, Spanish
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, Dental
Portfolio:
26-100
Onboarding time:
7–30 days
Pricing model:
Retainer
Starting from:
AUD 7,500
Included services:
Conformity assessment evidence mapping (EU/UK/US/CA), Annual ARTG charge reminders and continuity planning, eBusiness Services account setup support, Sponsor address and labeling review
Supports Artg:
Yes
Device Classes Supported:
IVD
Evidence Review:
Yes
Australian Entity State:
Sydney
Recall Vigilance Support:
No
Fsca Recall Support:
No
Additional tga_sponsor_au Details
Device Classes Supported
All device classes requiring ARTG registration
Supports Artg
Yes
Australian Entity State
Sydney
Onboarding Steps
Requires ARTG registration for medical devices and IVDs, including application review and potential documentation review based on device classification.
