Evidence Alignment with the Mainland, Hong Kong and the EU

1. Key takeaways

On evidence alignment, the Macao medical device regime takes the approach of Chinese standards first, international standards in support: Article 12(2) of Law No. 12/2025 provides that the quality standards for medical devices give first place to China’s mandatory national standards for medical devices (mandatory GB standards), and only where no corresponding mandatory national standard exists, or where that standard is insufficient in coverage, do other standards recognised by the Drug Administration (ISAF) apply. This differs both from the route of Hong Kong, China, where MDACS approvals are based on eight reference jurisdictions, and from the European Union route centred on CE conformity. For manufacturers from the Chinese mainland, this means existing NMPA technical documentation is the best foundation for a Macao submission; for companies whose principal evidence is European CE certification, additional standards benchmarking is required.

2. Legal basis

The instruments and provisions governing quality standards, classification and evidence alignment are listed below.

3. Expert insights

Insight one: Article 12(2) is the most mainland-manufacturer-friendly provision in the Macao regime. The order of priority for quality standards expressly names China’s mandatory national standards for medical devices. For products already tested in the mainland against GB standards, those test reports enjoy a natural basis of acceptance in Macao — saving substantial time and cost compared with running a fresh round of testing to ISO or ASTM standards.

Insight two: the classification catalogue provides certainty, and devices not listed can apply for class confirmation. The Classification Catalogue of Medical Devices of the Macao Special Administrative Region is approved by Chief Executive Dispatch No. 36/2026 of the Secretary for Social Affairs and Culture; for a medical device not listed in the catalogue, the applicant may apply to ISAF for confirmation of class, and the Government operates a classification service to assist the industry. Practical estimate: the application procedure for class confirmation, and whether it attracts a fee, are subject to the arrangements published by ISAF. Confirm the class first, then compile the dossier — this avoids building the file on the wrong track.

Insight three: the difference from Hong Kong’s MDACS lies in the reference object. The voluntary listing system of Hong Kong, China relies primarily on approvals in reference jurisdictions; Macao relies primarily on quality standards (GB) plus prior marketing in the place of origin, and additionally offers the Hengqin exemption. Practical estimate: the same overseas approval document plays a different role in the two places, and Hong Kong experience cannot be transplanted directly onto Macao.

Insight four: European CE evidence is second in line in Macao. A CE certificate can support the item on approval in the place of origin or place of marketing approval (Article 10(2)(13)), but at the level of quality standards benchmarking against China’s mandatory national standards is still required. The deficiency most often encountered by companies on a pure CE route arises precisely at the technical requirements and test report stage.

Insight five: the clinical evaluation exemption offers mature products a shortcut. Article 14(2) lists the situations in which clinical evaluation may be exempted: where the working mechanism is well understood and the design is settled and the manufacturing process mature, without change to conventional use; where a device of the same type has been in clinical use for many years with no record of serious adverse events; or other situations in which safety and effectiveness can be demonstrated through non-clinical evaluation. Mature products with years of clinical use in the mainland and no record of serious adverse events are best placed to use this route.

4. Practical recommendations

• Use NMPA technical documentation as the foundation for mainland manufacturers: focus on adding benchmarking statements against mandatory GB standards.
• Seek class confirmation before compiling the dossier: products not in the classification catalogue should apply for confirmation first.
• CE-route companies should perform standards benchmarking: do not assume a CE certificate satisfies the quality standard requirements.
• Prioritise the clinical evaluation exemption for mature products (Article 14(2)).
• Obtain documents evidencing marketing outside Macao early: Hengqin-manufactured products may rely on the exemption in Chief Executive Dispatch No. 142/2026.
• Localise labels and instructions for use in all three languages in parallel (Chinese, Portuguese and English).

5. Verification checklist

• □ The applicable order of priority of quality standards has been confirmed under Article 12(2)
• □ The product class has been confirmed in the classification catalogue (Chief Executive Dispatch No. 36/2026 of the Secretary for Social Affairs and Culture), or class confirmation has been applied for
• □ Technical requirements and the summary test report have been benchmarked against mandatory GB standards
• □ Documents evidencing marketing outside Macao are ready, or applicability of the Hengqin exemption has been confirmed
• □ Feasibility of the clinical evaluation exemption (Article 14(2)) has been assessed
• □ Non-clinical evaluation materials have been prepared under Article 10(2)(10)
• □ Name, labelling and instructions for use have been localised under Article 13 (Chinese, Portuguese and English)
• □ The boundaries for reusing evidence across the Chinese mainland, Hong Kong and the European Union have been mapped clearly

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