Reporting Serious Adverse Events within 24 Hours

1. Key takeaways

Article 29 of Law No. 12/2025 provides that where a registration holder or filer knows of the occurrence or suspected occurrence of a serious adverse event involving a medical device, it must notify the Drug Administration (ISAF) within twenty-four hours. This is the shortest mandatory time limit in the Macao medical device regime, and the trigger point is knowledge or suspicion, not confirmation of causation. In addition to the 24-hour notification, under the Guideline on Post-Market Adverse Event Notification and Reporting, tiered reporting follows: events resulting in death must be reported within 7 days from the day after discovery or awareness; events that may lead to death, or that cause or may cause serious harm to physical integrity, must be reported within 20 days; and serious adverse events occurring outside Macao must be reported within 30 days from the date of discovery or awareness.

2. Legal basis

The instruments and provisions governing the notification and reporting time limits described in this article are listed below.

3. Expert insights

Insight one: suspicion triggers the duty; no confirmation is required. The wording of Article 29(1) is that the holder or filer knows of the occurrence or suspected occurrence of a serious adverse event. In practical terms this eliminates the buffer zone in which companies first investigate internally and then decide whether to report. The sequence familiar to companies from the Chinese mainland — first judge causation, then decide whether to report — amounts directly to late reporting in Macao. The correct approach is to report first and investigate afterwards; notification does not amount to an admission of responsibility.

Insight two: the 24-hour notification is only the first layer; four further time limits follow. The tiered reporting after notification carries most of the workload: 7 days for deaths, 20 days for serious injury, 30 days for serious events occurring outside Macao, and 30 days (deaths) or 45 days (serious injury) for evaluation results. Companies should assign a responsible person and a template to every layer in advance; otherwise the first layer is barely met on time and every subsequent layer runs overdue.

Insight three: events occurring outside Macao also fall within the reporting scope. Sections 2.2.3 and 2.2.5 of the Guideline bring serious adverse events occurring outside Macao, as well as situations where control measures have been taken outside Macao, within the reporting obligation, and the latter likewise requires a report within 24 hours of awareness. This affects multinational companies using Macao as a regional node most of all — a recall or regulatory action taken in one market triggers an independent reporting obligation in Macao.

Insight four: the notification channels are multiple, but the evidential risk runs in one direction. The Guideline permits notification within 24 hours by telephone, fax or email, among other means. The burden of proving a telephone notification rests on the company — if a dispute later arises over whether notification was made on time, the company needs independently time-stamped records. Whatever channel is used, the recommendation is to generate a time-stamped record in the internal system at the same time.

Insight five: adverse event records feed directly into renewal materials. Article 18(2)(3) of the Implementation Rules requires a medical device adverse event monitoring report to be submitted at renewal. A nil report is still a report, but it must be a demonstrable nil — the company must be able to show that the monitoring mechanism was running and that there truly were no events, rather than that no monitoring existed at all.

4. Practical recommendations

• Establish a 24-hour duty roster and reporting chain: define who receives reports, who assesses them, and who notifies within the time limit.
• Report first, investigate afterwards: write suspicion-based notification into the SOP and prohibit internal investigation before reporting.
• Assign templates and owners to the four subsequent time limits: set separate reminders at 7, 20, 30 and 45 days.
• Bring events outside Macao into the same monitoring system: build mapping rules from global events to Macao obligations.
• Archive notification records independently: record the time, channel and content to preserve evidence for potential disputes.
• File the annual monitoring report together with the renewal package: even a nil report needs a documented trail.

5. Verification checklist

• □ The suspicion-triggered standard has been understood and written into the SOP
• □ The responsible person, channels and time-recording mechanism for 24-hour notification are in place
• □ Reporting processes for deaths within 7 days and serious injury within 20 days are configured
• □ A reporting process for serious adverse events occurring outside Macao within 30 days is configured
• □ Reporting processes for evaluation results within 30 days (deaths) / 45 days (serious injury) are configured
• □ A reporting process for the 24-hour report after control measures are taken outside Macao is configured
• □ Adverse event monitoring reports are archived by year and available for renewal
• □ The definition of serious adverse event (Article 2(8)) has been aligned across internal training

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