Transition Timeline for Medical Devices in Macao, China

1. Key takeaways

Law No. 12/2025 handles the transition in three articles, forming three independent timelines. Each timeline has its own legal basis, its own start and end dates and its own application deadline, and a single operator may be caught by all three at once.

• Medical devices already circulating (Article 67): the transition period for Class III and Class IIb runs from July 1, 2026 to June 30, 2029; for Class IIa from July 1, 2027 to June 30, 2030; and for Class I from July 1, 2029 to June 30, 2032. The interested parties must apply for registration or filing at least one year before the expiry of the transition period; otherwise the devices may no longer circulate in Macao, China after the transition period ends.
• Existing premises for import and export, wholesale or retail (Article 66): those engaging in Class IIb or Class III business must apply for a trading licence before July 1, 2027.
• Existing medical device manufacturing plants (Article 65): Class III and Class IIb plants must apply for a manufacturing licence before July 1, 2027, Class IIa before July 1, 2028, and Class I before July 1, 2030.

2. Legal basis

The three transition timelines and the related licence procedures derive from the following provisions.

3. Expert insights

Insight 1: The phrase at least one year is the true deadline. Article 67(3) requires interested parties to apply for registration or filing at least one year before the expiry of the transition period. Converted, the effective action deadlines fall at approximately June 30, 2028 for Class III and Class IIb, June 30, 2029 for Class IIa, and June 30, 2031 for Class I (practical estimate, subject to what ISAF publishes). Companies that treat June 30, 2029 as the final deadline will be a full year late.

Insight 2: The three timelines cannot substitute for one another. A device already circulating (Article 67) does not mean the premises are compliant (Article 66), nor that the manufacturing plant is compliant (Article 65). A single company may need to satisfy all three lines, each with its own independent deadline.

Insight 3: Filing an application extends the transition period. Article 66(3) and Article 65(3) both provide that where an application is duly submitted, the transition period is extended until the decision on the application is made. This is an important buffer design — by submitting first, the lawful status of continued operation is preserved.

Insight 4: Obligations during the transition are not all waived. Article 66(2) and Article 65(2) both state that premises and manufacturing plants in the transition situation remain subject to Article 43(1) and Article 56(1)(6) (prohibition on supply, administrative offences). What is waived is the licence, not the rules of conduct.

Insight 5: Article 72 lets Class I and Class IIa board early. From the entry into force of the law on July 1, 2026, Class I and Class IIa operators may already apply voluntarily for a manufacturing licence or a filing, and once issued, the law provides that it takes effect immediately for the premises or the device. Filing early means locking in the compliance position early and entering the ISAF public search system early. The voluntary route is available from the first day of the regime, alongside the transition periods.

4. Practical recommendations

• Build a separate ledger for each of the three lines: one table each for products, premises and manufacturing plants, each marked with the start and end of the transition period and the latest application date.
• Write the at-least-one-year rule into the project plan: set the internal deadline one year before the transition period expires, then reserve the approval cycle in front of it (70 working days for Class IIb, 100 working days for Class III).
• Submit first to extend the transition period: for licence applications, filing the form alone extends the transition period until the decision is made, avoiding a compliance gap.
• Evaluate early filing for Class I and Class IIa: for products with stable sales in Macao, filing early supports purchaser verification and channel stability.

5. Verification checklist

• □ Transition period start and end dates for each product class confirmed under Article 67
• □ Registration or filing submission dates scheduled at least one year before the transition period expires
• □ Trading licence application deadline for existing import/export, wholesale or retail premises confirmed under Article 66 (2027-07-01)
• □ Manufacturing licence application deadlines by class confirmed under Article 65 (July 1 of 2027/2028/2030)
• □ Pros and cons of early voluntary filing for Class I/IIa evaluated
• □ Matters subject to Articles 43 and 56 during the transition incorporated into internal controls

Regulatory information verified as of October 29, 2026. The regulations, guidance 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 have been updated, the latest 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 Health Bureau (SSM) pre-market registration and notification procedures, prepares Portuguese/Chinese-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com