Overseas Prior Approval and the Hengqin Exemption in Macao, China

1. Key takeaways

Article 9(2) of Law No. 12/2025 provides that medical devices manufactured outside Macao, China must, in order to be registered or filed in Macao, China, already be registered or hold a sale permit abroad; the exception is devices manufactured in regions designated by a Chief Executive dispatch published in the Official Gazette. The region designated by Chief Executive Dispatch No. 142/2026 is the Guangdong-Macao In-Depth Cooperation Zone in Hengqin — for medical devices manufactured in the Hengqin Cooperation Zone, the registration or filing application need not be accompanied by medical device registration or sale permit documents issued by the competent authority of the place of origin.

For manufacturers the provision has two practical faces. Devices manufactured in the Chinese mainland outside Hengqin, or in third countries, must carry proof of registration or a sale permit issued abroad before a Macao application can even be considered, so the overseas approval has to be planned as part of the Macao project rather than discovered at submission. Devices manufactured inside the Hengqin Cooperation Zone enjoy the designated-region exception, and the application proceeds without the origin registration or sale permit documents.

2. Legal basis

The precondition for devices manufactured abroad and the Hengqin exception are grounded in the following instruments and published materials.

3. Expert insights

Insight 1: This is the most distinctive provision in Macao compared with Hong Kong, China and the Chinese mainland. The MDACS scheme in Hong Kong, China accepts marketing approvals from reference jurisdictions, which is a form of evidence borrowing; Article 9(2) of Macao is a precondition — without an overseas marketing approval, in principle the applicant does not even have standing to apply. The two have different legal natures, and in practice a product may be eligible in Hong Kong, China while not yet eligible in Macao.

Insight 2: The Hengqin exemption writes industrial policy directly into the access rules. The legislative purpose of promoting the diversification of the greater health industry lands precisely on this provision: setting up a plant in Hengqin means bypassing the gate of first obtaining approval in the place of origin. For innovative products that have not yet obtained overseas approval, this is the only realistic access route into Macao. The dispatch was published on the same day as the other supporting instruments, so the exception applies from the first day of the regime.

Insight 3: The proof must be issued by the competent authority or an authorised body. Article 10(2)(13) of the implementing regulation requires documents proving the marketing of the medical device that are issued by the competent authority or an authorised body of the country or region of origin or of the country or region where approval for marketing was obtained. Certificates from industry associations, distributor statements and self-declarations do not satisfy the formal requirement.

Insight 4: The proof must be submitted again at renewal. Article 18(2)(2) of the implementing regulation lists Article 10(2)(13) among the documents that must be submitted for renewal. The validity of the overseas approval is a continuing obligation, not a one-time threshold.

4. Practical recommendations

• Confirm the manufacturing site first: devices manufactured within the Hengqin Cooperation Zone may be exempted from the overseas marketing proof; devices manufactured elsewhere in the Chinese mainland or in third countries must obtain it.
• Obtain the overseas marketing proof early: the document must be issued by the competent authority or an authorised body, and processing usually takes on the order of months (practical estimate); allow lead time before the registration submission.
• Track the validity of the proof in the ledger: it must be submitted again at renewal, and the expiry of the overseas approval will affect the renewal of the Macao registration.
• Evaluate a Hengqin footprint: for innovative product lines without overseas approval, manufacturing in Hengqin is a feasible way to bypass the precondition and should enter capacity planning.

5. Verification checklist

• □ Actual manufacturing location of the medical device confirmed
• □ For manufacturing within the Hengqin Cooperation Zone, exemption basis prepared (Chief Executive Dispatch No. 142/2026)
• □ For other regions, marketing proof issued by the competent authority of the place of origin or of the approval market obtained
• □ Issuing body of the proof meets the requirement of a competent authority or authorised body
• □ Validity period of the proof tracked in the ledger and covering registration and renewal
• □ Feasibility of a Hengqin footprint evaluated

Regulatory information verified as of October 29, 2026. The regulations, guidance and effective dates described in this article are limited to the content published by the official sources listed under Legal basis as of that date; where official documents have been updated, the latest published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Macao, China. Our team manages Health Bureau (SSM) pre-market registration and notification procedures, prepares Portuguese/Chinese-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com