Inspection Powers of the Drug Administration

1. Key takeaways

The medical device regime of Macao, China confers two categories of inspection powers on the Drug Administration (ISAF), which differ in source and in context. The first is the premises inspection during registration review: Article 12(3) of Law No. 12/2025 provides that, in order to review whether a medical device for registration or filing meets the requirements, ISAF may inspect the development and manufacturing premises designated by the applicant and the related documents; Article 14 of the Implementation Rules (inspection for registration) makes this an independent stage of the registration procedure. The second comprises the on-site powers in the licensing and supervision context: Article 42 provides that ISAF has the authority to inspect the technical conditions of premises and the facilities and equipment within them, and may request assistance from other public departments and entities; Article 48 further provides that inspectors exercising their duties enjoy the powers of a public authority and may request the assistance of the police and the administrative authorities.

2. Legal basis

The instruments and provisions governing inspection and related powers are listed below.

3. Expert insights

Insight one: the inspection targets under Article 12(3) include development premises, a point often overlooked. In many jurisdictions production-site inspections cover only the manufacturing plant, whereas the Macao provision expressly names development premises. This means research laboratories and design and development sites are also within the scope of inspection — the design history file, design verification and validation records and risk management documentation must all be retrievable on site.

Insight two: inspection is an independent stage of the registration procedure and consumes review time. Article 11 of the Implementation Rules divides the registration procedure into stages, with Article 14 dedicating one to inspection for registration. Once an inspection starts, the running of the review period changes accordingly — Article 17 counts from the date on which the materials are complete, while procedures connected with inspection are counted separately. Companies must build the uncertainty of inspection into their scheduling buffers.

Insight three: manufacturing premises outside Macao are equally subject to inspection, and this is the real cross-border compliance difficulty. The overwhelming majority of devices on the Macao market are manufactured elsewhere. The wording of Article 12(3) is the development and manufacturing premises designated by the applicant, with no limitation to Macao territory. Practical estimate: how inspections of overseas premises are actually conducted (self-inspection, engagement of a local body, or reliance on third-party reports) is subject to ISAF’s current practice and technical directives, and companies should confirm this proactively at the pre-procedural consultation stage.

Insight four: Article 48 gives inspectors the powers of a public authority, and the duty to cooperate is statutory. The owner or person in charge of premises must allow entry, produce and provide documents, and supply samples for testing; where a violation is found, a record of facts must be drawn up. Refusal to cooperate escalates the nature of the problem in itself — what might otherwise be a rectification matter may, through refusal, move to the administrative or even criminal level (the offence of disobedience under Article 52).

Insight five: inspection findings connect directly to subsequent measures. Problems found during inspection lead, at the lighter end, to correction of deficiencies under Articles 37 and 48, and, at the heavier end, to the preventive and control measures of Article 50 (recall, sealing, suspension of premises operations, precautionary seizure, destruction). Companies should prepare for an inspection as the starting point of risk management, not as a visit to be hosted.

4. Practical recommendations

• Prepare development and manufacturing premises in parallel: the design history file and risk management documentation must be available on site.
• Confirm the inspection method for overseas premises at the pre-procedural consultation stage: clarify the form of evidence early.
• Build inspection-related timing uncertainty into scheduling: do not plan on the assumption that no inspection will take place.
• Establish an on-site cooperation SOP: who accompanies, who retrieves files, who signs — rehearsed in advance.
• Handle inspection findings by risk level under Article 50: do not settle for minimum rectification.
• Maintain registration and archiving (Articles 71 and 72) as a routine: these are the primary source of evidence at inspection.

5. Verification checklist

• □ It has been confirmed that inspection targets include both development and manufacturing premises (Article 12(3))
• □ The inspection stage of the registration procedure (Article 14) is built into scheduling
• □ The inspection method for manufacturing premises outside Macao has been confirmed at the pre-procedural consultation stage
• □ An on-site cooperation SOP is in place (accompaniment, file retrieval, sign-off)
• □ The cooperation duties under Article 48 have been trained to the persons in charge of premises
• □ Registers for manufacturing activities (Article 71) and business activities (Article 72) are complete
• □ Premises layout, facilities and equipment (Chief Executive Dispatch No. 36/2026 of the Secretary for Social Affairs and Culture) meet the requirements
• □ The process for handling inspection findings is tiered by the risk levels of Article 50

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