Legislative History of the Medical Device Regime in Macao, China

1. Key takeaways

Before this reform, Macao, China had no dedicated law regulating medical devices. Law No. 12/2025 on the regime of supervision and administration of medical devices was passed by the Legislative Assembly on July 14, 2025, published on July 28, 2025 in Official Gazette No. 30/2025, and entered into force on July 1, 2026. The accompanying Administrative Regulation No. 11/2026, the implementing regulation of the same regime, was published on May 18, 2026 (Official Gazette No. 20/2026) and also took effect on July 1, 2026. Together with four Chief Executive dispatches, two dispatches of the Secretary for Social Affairs and Culture and more than twenty technical instructions, Macao, China completed the construction of an entire regulatory system from nothing within a single day.

2. Legal basis

The legislative chronology and the supporting instruments are documented in the sources below, as published in the Official Gazette of the Macao Special Administrative Region and in government and ISAF materials.

3. Expert insights

Insight 1: The legislative purpose includes a clause on promoting the diversification of the greater health industry. When the law was published, the authorities made clear that beyond safeguarding quality, effectiveness and safety, the regime also aims to provide the legal foundation for developing a medical device industry in Macao. This means the instrument is not only a regulatory law but also an industrial policy law. Only by understanding this can one understand why arrangements such as the Hengqin Cooperation Zone exemption exist at all.

Insight 2: The scale of the supporting instruments is itself information. Unlike most markets that operate with one law plus a handful of guidelines, Macao, China introduced in a single stroke one law, one administrative regulation, four Chief Executive dispatches, two dispatches of the Secretary for Social Affairs and Culture, and more than twenty ISAF technical instructions. The technical instructions go down to the level of separate GMP documents by device type — one each for sterile devices, implantable devices, in vitro diagnostic reagents, stand-alone software and custom-made dentures. This granularity signals that ISAF intends to conduct substantive review along the lines of the IMDRF framework and the Chinese mainland GMP, not merely formal filing.

Insight 3: The old concept of small medical devices has been formally abolished. Administrative Regulation No. 11/2026 specifically amends the wording of Administrative Regulation No. 35/2021, replacing small medical devices with medical devices and replacing registration of small medical devices with registration and filing of medical devices. This shows that a limited device registration arrangement previously existed in Macao, and the new regime is a wholesale replacement rather than an addition. Companies should not carry over experience from the old registration arrangement.

Insight 4: Entry into force and production of effects are two different concepts. Article 72 handles the matter in three paragraphs: the law enters into force on July 1, 2026; however, the provisions on filing and licences produce effects for Class IIa from July 1, 2027 and for Class I from July 1, 2029; at the same time, Class I and Class IIa devices may apply voluntarily and in advance from July 1, 2026. This is the provision most easily misread in the entire regime.

4. Practical recommendations

• Do not rely on how registration used to work in Macao: the old concepts have been repealed, and every determination must be redone under the new regime.
• Distinguish entry into force from production of effects under Article 72: the registration obligation for Class IIb and Class III applies from July 1, 2026; Class IIa and Class I are deferred to July 1, 2027 and July 1, 2029 respectively.
• Consider filing voluntarily in advance: Article 72(3) allows Class I and Class IIa devices to apply early from July 1, 2026, and once the filing notice is issued the law provides that it takes effect for the device immediately — early filing locks in the compliance position sooner.
• Build a tracking list of ISAF technical instructions: the twenty-plus instructions are the true operational basis for practice, and the applicable version of each must be checked one by one.

5. Verification checklist

• □ Passage date of the law (2025-07-14), publication date (2025-07-28) and effective date (2026-07-01) recorded
• □ Publication date of the implementing regulation (2026-05-18) and effective date (2026-07-01) recorded
• □ Production-of-effects date for the company product classes determined under Article 72
• □ Whether Class I/IIa devices should file voluntarily in advance evaluated
• □ Tracking list of ISAF technical instructions established and versions checked one by one
• □ Confirmed that the old small medical device framework is no longer relied upon

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