Need an MHRA Certificate of Free Sale for Australia? Ginkgo Advisory helps UK exporters review the certificate, confirm the recipient’s instructions and prepare the appropriate professional authentication.
Our services include express solicitor certification for suitable documents, an express 2-working-day apostille service for eligible prepared documents, and embassy legalisation where needed. We confirm the required route and timing before work starts.
Does Australia require an MHRA CFS for medical devices?
The TGA regulates Australia’s medical-device market. The US International Trade Administration’s Australia guide describes the TGA, ARTG and sponsor arrangements. Confirm the Australian sponsor’s own obligations and keep its regulatory application separate from a buyer’s CFS request.
Consult the US International Trade Administration’s Australia medical-device guide and ask Therapeutic Goods Administration (TGA) to clarify the particular document request.
Match the certificate to the Australian sponsor and device kind
The Australian sponsor should identify the exact device kind and manufacturer covered by its file. Compare those details with the CFS schedule before authentication. Ask whether the request concerns ARTG-related evidence, a tender or supplier checks. Do not assume another sponsor’s existing entry settles the new sponsor’s obligations or makes a general free-sale certificate sufficient.
Before arranging authentication, confirm:
- Who is the Australian sponsor?
- Which manufacturer and device kind does its file cover?
- Why does the sponsor request an authenticated CFS?
Illustrative example: A second Australian distributor wants to supply a UK device that another company already sells. The new sponsor checks its own TGA obligations while the exporter prepares the CFS requested for its supporting file.
Solicitor verification and express certification
Our solicitor-led review checks the complete certificate, manufacturer details, product schedules and evidence of origin. We compare the package with the recipient’s instructions and identify discrepancies. Our express solicitor certification service covers suitable copies and supporting documents where the receiving body accepts that certification. A true-copy statement alone does not establish the issuer document’s authenticity.
MHRA electronic certificates need a specific check. The MHRA’s CFS guidance directs exporters to a notary for authenticity checks and any required notarisation before FCDO authentication of its electronically signed PDF. We identify that step during review. Solicitor certification cannot replace a required notarial act.
Express 2-working-day apostille for Australia
Our express UK apostille service applies to the eligible FCDO stage after the document is ready. Allow separate time for MHRA issuance, authenticity checks, professional preparation, translation and delivery. Any consular processing also takes additional time. Extra FCDO checks can affect the timetable.
An apostille authenticates the relevant signature, seal or stamp. It does not confirm product safety, expand the certificate’s product list or grant local market access. The UK government’s legalisation guidance explains the authentication process.
Apostille or embassy legalisation for Australia?
Australia appears in the HCCH Apostille Convention status table. For qualifying public documents, an apostille generally replaces consular legalisation where the Convention operates between the UK and the destination. Check the applicable treaty relationship and the recipient’s instructions for the actual document.
Some administrative documents that deal directly with commercial or customs operations fall outside the Convention’s scope. We assess the certificate and the professional act involved. If the applicable route requires further diplomatic authentication, ask about our embassy legalisation service.
Preparing your MHRA Certificate of Free Sale for Australia
Confirm whether the recipient accepts the English certificate or requests English. Ask which translation formalities apply and whether the translation must include the annexes, professional certification and apostille. Keep the original issuer PDF intact for authenticity checks.
- Send the complete issuer PDF and every product schedule, plus any existing professional certification.
- Include the written checklist, recipient’s name and address, intended use and required submission format.
- Provide the deadline, number of copies and delivery details so we can confirm the scope and quote.
Frequently asked questions
Does a UK CFS place a device on the ARTG?
No. The TGA generally requires ARTG inclusion before supply unless an exemption applies. The sponsor must establish the applicable route; an apostille does not create an ARTG entry.
Does the two-working-day service include the complete export process?
No. It concerns the eligible apostille stage after preparation. Certificate issuance, authenticity checks, any notarisation, translation, embassy work and delivery have separate timescales. We explain the complete requested package before you proceed.
Does an MHRA medical-device CFS cover medicines and cosmetics?
This service page concerns medical devices and in vitro diagnostic devices (IVDs). Medicines, cosmetics and other products can need different certificates. Send the actual document and product description so we can identify the appropriate document service.
Request a CFS document review for Australia
Contact Ginkgo Advisory with the certificate and recipient’s checklist. We will quote for suitable solicitor certification, any required professional preparation, the eligible express apostille stage and embassy legalisation where applicable.