Product Traceability and Recall Obligations

1. Key takeaways

Article 16(5) of Law No. 12/2025 requires registration holders and filers to establish and execute product traceability and recall systems, and to notify the Drug Administration (ISAF) promptly of product recalls. The mandatory force of this system operates in two directions at once: the first is the company’s own proactive duty of execution (Article 16); the second is the regulator’s intervention powers exercisable on its own initiative — Article 50 provides that where a risk to public health and safety arises, ISAF may order measures including recall of all or part of a batch, temporary prohibition or restriction of business, suspension of premises operations, sealing, precautionary seizure, and destruction. In addition, where a registration is suspended, cancelled or lapses (Article 22), or where a filing is revoked (Article 27), the holder or filer bears the statutory consequence of recalling the devices concerned.

2. Legal basis

The instruments and provisions governing traceability, recall and related regulatory intervention are listed below.

3. Expert insights

Insight one: traceability is the precondition for recall, and the law deliberately places both in the same item. Article 16(5) is worded as a duty to establish and execute a product traceability and recall system — without traceability capability, recall is an empty phrase. When designing the system, a company should first answer this question: within a defined period, can it locate which institutions and which patient-level nodes a given batch reached? That capability is the key to whether the system can actually function.

Insight two: prompt notification is an independent obligation, not an accessory act of recall. Beyond recall itself, the article separately requires the company to notify ISAF promptly of product recalls. This means that even where the recall action is executed by an overseas head office or a contracted party, the registration holder or filer in Macao still bears an independent duty of notification. The mistake multinationals commonly make is waiting for a unified line from head office and missing the notification window.

Insight three: there is more than one trigger for recall. At least three situations give rise to recall: a company’s own decision; an order for preventive and control measures under Article 50; and the statutory effects of suspension, cancellation or lapse of registration (Article 22) or revocation of a filing (Article 27). The third category is the easiest to overlook — when a registration lapses for failure to renew, the holder must still recall the devices concerned.

Insight four: the list of measures under Article 50 goes far beyond recall. It includes recall of all or part of a batch, temporary prohibition or restriction of business, suspension of premises operations, sealing, precautionary seizure and destruction. This is a complete toolbox of risk responses, and a company cannot prepare only a recall plan. Suspension of premises operations in particular cuts off business continuity directly and should be assessed separately in the business continuity plan.

Insight five: registration and archiving duties are the verifiable foundation of the traceability system. Article 71 (registration and archiving of manufacturing activities) and Article 72 (registration and archiving of business activities) of the Implementation Rules provide the record carriers for traceability. What ISAF examines at inspection is precisely these registers, not explanatory material compiled by the company after the fact. Practical estimate: the specific register items and retention periods are subject to the technical directives issued by ISAF and to on-site guidance.

4. Practical recommendations

• Build traceability first, then write the recall plan: use the batch as the master key and connect purchasing, sales, inventory and end-user nodes.
• Treat prompt notification of ISAF as an independent step: notify first and supplement later, without waiting for the head-office line.
• Plan against the full Article 50 list: prepare not only for recall but also for sealing, seizure and suspension of premises.
• Add lapse of registration and revocation of filing to the recall trigger list: avoid devices continuing to circulate after a licence status change.
• Maintain the registers under Articles 71 and 72 as a routine: these are the primary source of evidence at inspection.
• Run at least one recall exercise every year: the exercise record is itself proof that the system operates effectively.

5. Verification checklist

• □ The product traceability system is established and can locate batch-level distribution
• □ The recall system is established and validated through exercises
• □ The independent process and owner for prompt notification of ISAF are defined
• □ Response plans for the six categories of preventive and control measures under Article 50 are drafted
• □ The recall obligations upon suspension, cancellation or lapse of registration (Article 22) are built into processes
• □ The recall obligations upon revocation of a filing (Article 27) are built into processes
• □ Registration and archiving of manufacturing activities (Article 71) and business activities (Article 72) are maintained routinely
• □ The storage and supply requirements (Article 69) are implemented in premises management

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