Registrant Obligations under Macao’s Medical Device Law

1. Key takeaways

Article 16 of Law No. 12/2025 sets out, in a dedicated article, the obligations of registration holders and filers, six in total: (1) ensure that medical devices meet the quality standards and requirements for registration and filing; (2) establish a quality management system appropriate to the medical devices and keep it operating effectively; (3) formulate post-market study and risk control plans and ensure their effective implementation; (4) conduct medical device adverse event monitoring and post-market evaluation, and notify the Drug Administration (ISAF) of serious adverse events and submit reports on them; (5) establish and execute product traceability and recall systems, and notify ISAF promptly of product recalls; and (6) allocate and maintain the resources required to fulfil the obligations in this article. The article binds registration holders and filers alike — Class I and Class IIa devices going through the filing route do not carry lighter obligations simply because the procedure is simplified.

2. Legal basis

The instruments and provisions underpinning the obligations described in this article are listed below.

3. Expert insights

Insight one: the six obligations are parallel and continuous, not one-off steps completed once a certificate is obtained. Article 16 is worded as a requirement that registration holders and filers comply with the obligations listed below, and the six obligations carry no ranking and no sequence. The mistake companies make most often is to treat the quality management system (the second obligation) as documentation to be submitted at application time, whereas the law requires a system to be established and kept operating effectively — a continuing state of affairs, not a static document.

Insight two: filers bear obligations identical in origin to those of registration holders, and this is the most underrated feature of the new legislation. Class I and Class IIa devices go through filing, and formal review takes only 5 working days, which looks undemanding; but Article 16 names registration holders and filers in the same sentence, and the six obligations apply as a single package. GRZAN keeps repeating one point to clients from the Chinese mainland: what filing saves is pre-market time, not post-market responsibility.

Insight three: the sixth obligation, to allocate and maintain the necessary resources, is a catch-all clause and an enforcement handle. The first five obligations are specific duties of conduct; the sixth requires resources to be allocated and maintained for performing them. The legislative intent is to remove lack of funds or lack of staff as a defence — during inspections or investigations the regulator can go straight to staffing levels, budget arrangements and the division of responsibilities, without first having to prove that any specific obligation was breached.

Insight four: performance of these obligations flows back into renewal review. Article 18 of the Implementation Rules requires, among the materials for renewal of registration, a medical device adverse event monitoring report. This means the documented performance of obligation (4) of Article 16 will be formally examined at the five-year renewal point set by Article 20. Scattering adverse event records across the separate files of customer service, sales and quality departments is the most common source of lost marks at renewal.

Insight five: Article 16 is directly connected to the penalty regime. Chapter V of Law No. 12/2025 establishes a complete framework of criminal and administrative liability. The obligations are not declaratory provisions — failure to perform them may simultaneously trigger the handling of administrative offences and preventive and control measures (Article 50). Companies should use Article 16 as the table of contents of their internal compliance manual.

4. Practical recommendations

• Turn Article 16 into the six-chapter table of contents of an internal compliance manual: each obligation maps to one process, one set of records and one responsible person.
• Build the quality management system for continuous operation: retain records of internal audits, management reviews and corrective and preventive actions.
• Consolidate adverse event records under a single owner: provide one data source for the monitoring report required at renewal.
• Give the resource clause concrete form in posts and budgets: define dedicated personnel, the division of duties and an annual budget.
• Filing-based products belong under the same obligation ledger: a simplified procedure does not exempt them from post-market management.

5. Verification checklist

• □ Each of the six obligations has been mapped to an internal owner and process
• □ The quality management system has been established and kept operating effectively, with internal audit and management review records
• □ The post-market study and risk control plan has been formulated and implemented
• □ The adverse event monitoring mechanism is in place and the 24-hour notification route for serious adverse events is defined
• □ The product traceability and recall system has been established and exercised
• □ Personnel, duties and budgets (Article 16(6)) are in place
• □ Filing-based products are covered by the same obligation management
• □ The adverse event monitoring reports required for renewal have been archived by year

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