MHRA Certificate of Free Sale for Taiwan: Solicitor Verification, Express Apostille and TRO Authentication

Exporting medical devices to Taiwan? Your MHRA Certificate of Free Sale for Taiwan needs the correct verification, certification and authentication before it can support your intended submission.

Ginkgo Advisory provides solicitor-led document review, express solicitor certification where accepted, an express 2-working-day UK apostille service for eligible prepared documents, and Taipei Representative Office authentication where required.

We help manufacturers, UK Responsible Persons, exporters and Taiwan distributors prepare their UK documents with the receiving authority’s requirements in mind.

What Is an MHRA Certificate of Free Sale?

An MHRA Certificate of Free Sale, commonly called a CFS, is an export document issued by the UK Medicines and Healthcare products Regulatory Agency for eligible registered medical devices and in vitro diagnostic devices.

It describes the relevant free-sale status of the listed devices. It is not a government endorsement of the products or confirmation that all export requirements have been met. This certificate route concerns medical devices; medicines and other products require separate consideration.

For exporters comparing different certificates, read our guide to the UK MHRA Certificate of Free Sale compared with an EU CFS.

What Does Taiwan Require from a Free Sale Certificate?

The Taiwan Food and Drug Administration — TFDA publishes requirements for manufacture and free-sale certificates used in medical-device licence applications.

These include device names and models or specifications, manufacturer details, manufacturing status and domestic-sale status. Its guidance generally requires authentication by a Taiwan overseas representative office, subject to specified exemptions. It states a two-year validity period from issuance.

Before ordering legalisation, ask your Taiwan applicant to confirm that your certificate covers the correct products, manufacturing sites and application route.

An MHRA certificate does not automatically establish UK manufacture: eligible UK Responsible Persons can also order certificates. Where manufacturing takes place elsewhere, confirm whether Taiwan requires additional manufacturing evidence or a different combination of certificates.

Our guide to why a UK Certificate of Free Sale may be rejected overseas explains why checking the certificate’s suitability before authentication matters.

Our Solicitor Verification and Express Certification Service

We begin with a review of your MHRA certificate and the instructions supplied by your Taiwan distributor, regulatory representative or receiving organisation.

We review:

• The certificate and its product schedules.
• Manufacturer, applicant and company details.
• The required certification wording.
• Available evidence of issuance and authenticity.
• Whether the requested route requires a solicitor, a notary or additional verification.

Certifying a copy and verifying its source are different tasks. The certification must accurately describe the checks performed.

Our express solicitor certification service is available for suitable documents where the receiving organisation accepts solicitor certification. We confirm the required evidence, format and wording before proceeding.

Does an MHRA Certificate Need a Notary?

MHRA issues its certificates as electronically signed PDFs. Its published legalisation guidance describes a notary checking authenticity with MHRA and notarising the certificate before FCDO legalisation. A standard solicitor-certified printout should therefore not be assumed to satisfy that route.

Our solicitor-led review identifies the appropriate preparation and any required notarial involvement. Express solicitor certification can also assist with suitable supporting documents, subject to their individual requirements.

Express 2-Working-Day Apostille Service for Taiwan

Once the documents are correctly prepared, Ginkgo Advisory offers an express 2-working-day FCDO apostille service for eligible submissions.

The apostille authenticates the relevant signature, stamp or seal. It does not establish that the device qualifies for registration in Taiwan. FCDO also advises applicants to confirm whether the recipient requires an original, a certified copy or certification by a particular professional.

For our Taiwan authentication service, we plan the submission around a paper FCDO apostille, followed by the representative-office stage where required. See our Taipei Representative Office authentication guide.

The two-working-day service applies to the apostille stage after the documents are ready and accepted for processing. Certificate issuance, source verification, notarisation, TRO authentication, translation and courier delivery require additional time. FCDO processing can also take longer where further signature checks are necessary.

Visit our UK apostille service page to enquire about an urgent submission.

Taipei Representative Office Authentication for Taiwan

Where Taiwan requires representative-office authentication, obtaining the UK apostille is one part of the process.

Ginkgo Advisory can assist with preparing the application, the paper apostille, Taipei Representative Office — TRO — authentication, and onward delivery. We check the relevant office and submission requirements for your documents before proceeding.

For an MHRA certificate requiring the full process, the preparation will typically involve:

1. Reviewing the certificate and Taiwan recipient’s instructions.
2. Completing the required authenticity checks and notarial preparation.
3. Obtaining the paper FCDO apostille.
4. Submitting for TRO authentication.
5. Arranging delivery of the completed documents.

Although this is sometimes searched for as “Taiwan embassy legalisation”, the relevant UK service is provided through the Taipei Representative Office.

Read our TRO London authentication requirements guide and embassy and representative-office legalisation service page for related information.

Does an English MHRA Certificate Need Chinese Translation?

Chinese translation is not automatically required for an English certificate under TFDA’s published certificate instructions. For certificates issued in another language, those instructions require an authenticated Chinese or English translation. Check separate requirements for the rest of your submission.

Send us any translation instructions from your Taiwan representative when requesting a quotation, so the document preparation and authentication can be planned together.

Taiwan’s Electronic Filing Update from October 2026

From 1 October 2026, TFDA is trialling an electronic review procedure for specified medical-device applications. Required original documents, including manufacture and free-sale certificates, are uploaded as colour PDF scans, while the applicant or licence holder retains the paper originals for inspection.

This notice changes how documents are submitted and retained. It should not be treated as confirmation that an otherwise applicable authentication requirement has been removed.

Ask your Taiwan applicant which filing procedure applies, and retain the completed authenticated documents for any subsequent checks.

What Should You Send Us?

To begin your MHRA Certificate of Free Sale verification and legalisation for Taiwan, send:

• The original MHRA PDF, including every annex and product schedule.
• Any issuance email or supporting verification information.
• The Taiwan recipient’s written requirements.
• Details of supporting documents needing certification or legalisation.
• Your deadline and delivery destination.

Start with electronic copies so we can identify the correct preparation before you post originals.

Where your submission also includes company records, manufacturer authorisations or other commercial documents, include these in the initial enquiry. Different documents may require different signing and certification arrangements.

Why Choose Ginkgo Advisory?

Our certification and apostille work is overseen by KH Lam, a practising solicitor in England and Wales, regulated by the Solicitors Regulation Authority and registered with the FCDO for apostille purposes.

We bring document review, suitable solicitor certification, apostille preparation and representative-office authentication into one coordinated service.

For urgent export documentation, we explain which stages can proceed immediately, which require additional evidence, and how the apostille timetable fits your overall deadline.

Frequently Asked Questions

Can the entire Taiwan legalisation process be completed in two working days?

Our express two-working-day service covers the eligible apostille stage. Any preliminary verification, notarisation, TRO processing and delivery must be allowed for separately.

Can I start the process from Taiwan?

Yes. Send the certificate and receiving authority’s instructions electronically for an initial review. We will explain any original-document, identity or authorisation requirements before proceeding.

Does legalising an MHRA certificate guarantee TFDA approval?

No. Authentication and regulatory acceptance are separate matters. Your Taiwan applicant must establish that the certificate and remaining dossier satisfy the requirements for the device and application concerned.

Can I use an e-Apostille for this service?

Our Taiwan TRO service is planned around a paper apostille. Check the intended authentication route with us before ordering an electronic apostille.

Can you help with supporting company documents?

Yes. Send the documents and recipient’s instructions together so we can assess their suitability for solicitor certification and identify any separate signing or authentication requirements.

Request MHRA Certificate Legalisation for Taiwan

Need solicitor verification, express certification, a 2-working-day apostille service or TRO authentication for an MHRA Certificate of Free Sale for Taiwan?

Contact Ginkgo Advisory with your certificate, Taiwan recipient’s requirements and deadline. We will review the documents and confirm the appropriate service and quotation.

Email: apostille@ginkgoadvisory.com
WhatsApp: +44 7388 833283
Enquiries: Contact Ginkgo Advisory

Line: ginkgoadvisory