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Medical Device Registration with the Australian TGA

Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA).

Companies that have already acquired the European CE Marking for their medical devices will find the TGA process much easier since Australia recognizes the CE Marking. However, even if the medical device or IVD has CE Marking, it must still be registered with the TGA, and there is a mandatory audit for certain classes of products.

As part of our Australia TGA medical device registration services, we will:

  • Assess the Australian TGA registration requirements for your device(s).
  • Research the proper GMDN codes for your medical device(s).
  • Conduct a Technical File review to ensure completeness.
  • Assistance with compilation or review of clinical summary (a TGA requirement).
  • File documentation with the TGA.
  • Assess compliance with other regulatory requirements (prerequisite for TGA approval).

Medical Device Registration with the Singapore HSA

Before any medical device can be supplied in Singapore, the device must be registered with the Health Science Authority of Singapore (HSA) which is regulated by

Companies that have already acquired the European CE Marking for their medical devices will find the HSA process much easier since the HSA recognizes the CE Marking. However, even if the medical device or IVD has CE Marking, it must still be registered with the HSA.

As part of our HSA medical device registration services, we will:

  • Assess the HSA registration requirements for your device(s).
  • Research the proper GMDN codes for your medical device(s).
  • Conduct a Technical File review to ensure completeness.
  • Assistance with compilation or review of clinical summary (a HSA requirement).
  • File documentation with the HSA.
  • Assess compliance with other regulatory requirements (prerequisite for HSA approval).

CFDA Registration Service

Medapproval provides the professional CFDA registration service, including medical device and IVD product CFDA registration, clinical trial and consulting services.


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Contact us

11555 Medlock Bridge Rd, Ste. 100
Johns Creek, Georgia 30097

qara@Medapprovalllc.com

1 (864) 735-2466

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