Acrapack Regulatory Consultants

Acrapack provide focused, tailored solutions to achieve your market visions locally and globally.

Acrapack can register your medical device

To supply a Medical Device or IVD device in Australia, you need to include the device on the Australian Register of Therapeutic Goods (ARTG) regulated by the Australian Therapeutic Goods Administration (TGA).

If your medical device already has market authorisation from overseas regulators comparable to the TGA such as;

  • Certificates issued by Notified Bodies designated by the medical device regulators of European union member states, under the medical device regulatory frameworks of the European Union (Medical devices directives, IVD Directive, Medical Device Regulation, or IVD Regulation
  • Decisions of the United States Food and Drug Administration (FDA)
  • Approvals and licences issued by Health Canada
  • Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB), which is applicable)
  • Certificates and reports issued under the Medical Device Single Audit Program (MDSAP) which include Australian regulatory requirements.
  • ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022)
  • ISO 13485:2016 certificates issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022).
The TGA process for inclusion of your medical devices in the Australian Register of Therapeutic Goods (ARTG) may be easier as the TGA recognizes the international assessments and approvals from these regulators. The devices are required to be the same design with the same intended purpose and with the same indications for use.

There are however certain products that will be subject to a TGA mandatory audit.

The TGA has also increased the use of assessment reports as the basis for abridgement of the assessment of an application for a TGA conformity assessment certificate.

Contact Acrapack to assist with the registering your medical or IVD device with the TGA and to gain access to the Australia healthcare market, we help;

  • Determine the Australian TGA registration requirements for your device(s).
  • Find the appropriate GMDN codes for your medical device(s).
  • By reviewing your medical device Technical File to ensure compliance to TGA requirements.
  • Prepare or review of the clinical summary for your medical device as required by the TGA.
  • Submit your device application and any required documents to the TGA with continued follow up as required.
  • Review compliance of your medical device with all regulatory requirements (prerequisite for TGA approval).

If you are an overseas company with no physical location in Australia or New Zealand, you will need an Australian sponsor or New Zealand sponsor or both for compliance to the regulations and for the registration processes in both countries. We offer Australian sponsor and New Zealand sponsor services under ACRA Regulatory Services.

Call Acrapack today on +61 400 284 808.

Contact Acrapack

“Anne is prompt and efficient in all aspects of the work that she carries out for our medical company in regards to our regulatory requirements with the TGA. She demonstrates an in depth knowledge of the processes and requirements. We look forward to continuing our solid relationship.”

Top qualities: Expert, Good Value, On Time
Robert Yee
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