The Hengqin Cooperation Zone Exemption from Place-of-Origin Marketing

1. Key takeaways

Article 9(2) of Law No. 12/2025 establishes the principle of prior marketing in the place of origin: medical devices manufactured outside the Macao Special Administrative Region must, in principle, already be registered or licensed for sale in their country or region of origin or in a country or region that has approved them for marketing. Chief Executive Dispatch No. 142/2026 designates the region referred to in that paragraph — the Guangdong-Macao In-Depth Cooperation Zone in Hengqin: for medical devices manufactured in the zone, applications for registration or filing need not be accompanied by medical device registration or sale-licence documents issued by the competent authority of the place of origin. This is the exemption in the Macao regime with the strongest regional industry orientation, and it is the lowest-cost route for manufacturers from the Chinese mainland to enter the Macao market.

2. Legal basis

The instruments and provisions governing the place-of-origin requirement and the Hengqin exemption are listed below.

3. Expert insights

Insight one: what is exempted is one document, not all requirements. Chief Executive Dispatch No. 142/2026 waives the proof of marketing in the place of origin as a piece of documentation. The mandatory registration and filing requirement of Article 9(1), the four requirements of Article 12, the quality standards and clinical evaluation requirements, and the six obligations of Article 16 — none of these is waived. Companies should not read this policy as meaning that Hengqin manufacture alone gives free entry to Macao.

Insight two: the exemption is most valuable for innovative products that hold no marketing authorisation anywhere. For products that already hold an NMPA registration certificate or a CE certificate, the place-of-origin requirement is little more than one more notarised document; but for innovative products still at the clinical stage or not yet approved in the mainland, obtaining proof of marketing in the place of origin is often the hardest step to cross. The Hengqin exemption removes that threshold directly, making Macao the first market where such products can land.

Insight three: manufacturing in Hengqin does not require the applicant to be a Hengqin entity. The connecting point of the exemption is the place of manufacture, not the place of registration of the applicant. Practical estimate: the applicant must still satisfy the legitimacy requirements of Article 11 (the self-manufacturing route or the licensed business operator route) and hold external trade operator qualifications and comparable arrangements. When designing the corporate structure, companies should treat place of manufacture and applicant entity as two variables to be optimised separately.

Insight four: this provision is directly tied to Macao’s policy goal of developing the greater health industry. The Macao SAR Government has expressly made promoting the diversified development of the greater health industry one of the purposes of the legislation. The Hengqin exemption is where industrial policy lands within the registration system — what it lowers is not only corporate cost but also the institutional cost of building local medical device supply and manufacturing capability in Macao. For companies planning a Macao-Hengqin dual base, this is a long-term positive.

Insight five: the route differs from the reference pathway of Hong Kong’s MDACS. The voluntary listing system of Hong Kong, China requires the product to have been approved in one of eight reference jurisdictions; Macao takes Chinese mandatory national standards as the first choice of quality standard and features the Hengqin exemption as its regional hallmark. Practical estimate: the specific arrangements for aligning evidence between the two places must be confirmed separately with the two regulators; experience in one cannot be extrapolated to the other.

4. Practical recommendations

• First determine whether the place of manufacture falls within the region designated by Chief Executive Dispatch No. 142/2026: the actual address of the manufacturing plant governs.
• Hengqin manufacture does not replace technical requirements: quality standards, clinical evaluation, and labelling and instructions for use requirements remain unchanged.
• Design place of manufacture and applicant entity separately: optimise compliance costs for each.
• Use this channel for innovative products: Macao registration can proceed even without proof of marketing in the place of origin.
• Retain documentation of Hengqin manufacture: the exemption must be evidenced, not merely asserted.
• Evaluate a Macao-Hengqin dual-base layout: plan long-term against the greater health industry policy.

5. Verification checklist

• □ The official text of Chief Executive Dispatch No. 142/2026 has been obtained and the designated region confirmed
• □ The manufacturing plant address has been confirmed to fall within the Guangdong-Macao In-Depth Cooperation Zone in Hengqin
• □ It has been confirmed that the exemption covers only the single item of proof of marketing in the place of origin
• □ The remaining registration and filing materials (Articles 10 and 21) are prepared as usual
• □ The applicant’s legitimacy (Article 11) has been verified independently
• □ Documentation of Hengqin manufacture is ready for verification by ISAF
• □ Quality standards (Article 12(2)) and clinical evaluation requirements have not been mistaken as exempted
• □ The long-term layout plan (Macao-Hengqin dual base) has been evaluated

Legal information verified as of October 29, 2026. The laws, guidelines and effective dates described in this article are limited to the published content of the official sources listed under Legal basis as of that date; where official documents are updated, the most recently 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 adverse event reporting and recall coordination with the Health Bureau, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com