Registration Changes and Prior Authorisation in Macao

1. Key takeaways

After registration of a medical device in Macao, China, changes to the registration information fall into two categories: notification and prior authorisation. Article 20 of Administrative Regulation No. 11/2026 (changes to registration) provides that, for changes requiring prior authorisation, the decision period is up to 100 working days, while notifiable changes are handled under the notification procedure. Article 23(2) of Law No. 12/2025 is the overarching legal basis for this classification, with the specific requirements set out in Dispatch No. 11/ISAF/2026. The first task in change management is to determine which category a change belongs to — a misclassification leads directly to the compliance risk of implementing a change without approval, and may even affect the validity of the registration.

• Changes to registration information are either notifiable or subject to prior authorisation.
• The decision period for changes requiring prior authorisation is up to 100 working days.
• Article 23(2) of Law No. 12/2025 is the overarching basis; Dispatch No. 11/ISAF/2026 details the requirements.
• Implementing a change requiring prior authorisation without approval is a separate violation.
• Change management must cover the entire registration dossier, not only the certificate particulars.

2. Legal basis

The change framework rests on the implementing rules, the parent law and the technical dispatch, with the fee schedule applying to certificate reissue. The table below lists the instruments and provisions cited in this article.

3. Expert insights

Insight one: 100 working days is a maximum decision period, not an average duration. The wording is up to 100 working days, comparable in magnitude to the registration decision periods of 70 (Class IIb) and 100 (Class III) working days. The intensity of the review of a change is not necessarily lower than that of the initial registration — especially for substantive changes affecting technical requirements, intended use or manufacturing processes. Practical estimate: schedule substantive changes on the basis of 100 working days plus 20 working days of formal review; do not assume that a change is faster than a registration.

Insight two: the dividing line between notification and prior authorisation lies in the impact on safety and effectiveness. Dispatch No. 11/ISAF/2026 enumerates which changes must be notified and which require prior authorisation. The underlying criterion is that matters not affecting the safety and effectiveness of the device go through notification, while matters that may affect them go through prior authorisation. Where classification is unclear, companies should consult the ISAF rather than default to the lighter category — this is the lowest-cost form of risk control.

Insight three: changes and renewal interact with each other. Registration is valid for 5 years, with the renewal window falling 90 to 180 days before expiry. If a major change is submitted close to expiry, the change review and the renewal review may run in parallel or conflict. It is advisable to schedule major changes in the first and middle parts of the certificate validity period, away from the renewal window.

Insight four: implementing a change without authorisation is a violation in its own right. Law No. 12/2025 establishes a system of administrative and criminal liability for violations of the regime. Changing first and reporting later is tolerated in some scenarios in the Chinese mainland, but under the legal framework of Macao, implementing a change requiring prior authorisation without obtaining it is itself a violation. Mainland enterprises localising into Macao need focused training on this point.

Insight five: change management must extend beyond the particulars printed on the certificate. Registration information is not limited to the few items on the certificate; risk analysis documents, technical requirements and test summary reports, clinical evaluation documents and quality management system documentation are all part of the registration dossier. Any substantive update to these documents may trigger the change procedure. Companies should maintain a dossier-to-change linkage list, rather than watching the certificate only.

4. Practical recommendations

• Build a change classification matrix: determine notification versus prior authorisation first, then run the procedure.
• Reserve 120 working days for major changes (20 working days of formal review plus 100 working days of decision period).
• Keep major changes away from the renewal window: schedule them in the first and middle parts of the certificate validity period.
• Prohibit change-first, report-later practice: write the prohibition into local SOPs and train teams from the Chinese mainland.
• Archive change records together with the dossier: create a paper trail for the next renewal and inspection.

5. Verification checklist

• □ Determined whether the change is notifiable or requires prior authorisation
• □ Changes requiring prior authorisation scheduled on the basis of up to 100 working days
• □ Formal review of 20 working days built into the schedule
• □ Change list of Dispatch No. 11/ISAF/2026 checked item by item
• □ Confirmed that the change avoids the renewal window (90 to 180 days before expiry)
• □ Red line of not implementing changes without authorisation embedded in internal SOPs
• □ Change documentation updated and archived together with the registration dossier
• □ Changes affecting labelling and instructions localised in parallel (Chinese, Portuguese, English)

Regulatory information verified as of 29 October 2026. The laws, guidelines 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 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 coordinates local licence holder arrangements, import and supply requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com