Effective-Day Compliance Checklist for Macao Medical Devices

1. Key takeaways

Law No. 12/2025 on the Regulatory Regime for Medical Devices and Administrative Regulation No. 11/2026 on the Implementation Rules both take effect on 1 July 2026. From that date, Macao ends the situation in which medical devices were governed by no dedicated law and enters dual-track mandatory management of registration (Classes IIb and III) and filing (Classes I and IIa). The actions a company must complete by the effective date can be grouped into four items: determine the product’s attributes and risk class, confirm the applicant’s legitimacy, confirm whether the product falls within transitional arrangements, and build the post-market obligation mechanisms. Devices that have not completed registration or filing may not circulate, except where a statutory exemption applies.

2. Legal basis

The instruments and provisions governing the effective date and the actions required by it are listed below.

3. Expert insights

Insight one: the effective date does not mean every device needs a certificate on the day itself. Article 72 phases the effect of certain provisions, and Article 65 sets transitional periods for devices already in circulation. Misreading the position as all uncertified products becoming illegal after 1 July leads to two wrong reactions: panic withdrawal of products from sale, or complete inaction in the mistaken belief that a buffer remains. The correct approach is to determine first whether a product falls within the transitional arrangements, and only then set the priority of actions.

Insight two: transitional periods fall into three tiers by risk class, and applications must be filed at least one year in advance. Article 65 sets transitional periods for medical devices already in circulation, with different periods applying to Classes III and IIb, Class IIa, and Class I respectively, and requires the application to be submitted at least one year before the transitional period expires. The one-year rule is an independent, hard requirement — an application filed only six months before expiry is non-compliant even though the transition itself has not yet ended.

Insight three: existing premises and existing manufacturing plants run on separate timelines. Article 66 targets existing premises carrying on medical device business activities, and Article 67 targets existing medical device manufacturing plants; the period arrangements of the two differ from Article 65. A company that is both a business operator and a manufacturer will be pulled along by two timelines at once and must schedule them separately.

Insight four: preparation that can be done before the effective date need not wait until after it. Classification determination, dossier compilation, obtaining proof of marketing overseas, localisation of labels and instructions for use, and preparation of quality management system documentation can all in principle begin after the law was published in July 2025. GRZAN’s basic judgement when advising clients is this: the length of the queue after the effective date depends on the depth of preparation before it.

Insight five: review the exemption list first — it may remove work outright. Article 9(3) lists the situations exempt from registration and filing; Article 8 provides exemptions from the import licence (including Class I and IIa devices for personal use valued at no more than MOP 5,000); and Chief Executive Dispatch No. 142/2026 exempts products manufactured in the Hengqin Cooperation Zone from the proof of marketing in the place of origin. Do the subtraction before the addition.

4. Practical recommendations

• Step one is the product inventory: determine for every SKU whether it is a medical device and which class it belongs to.
• Determine for every SKU whether transitional arrangements apply: check against Article 65 and mark the expiry date and the one-year-in-advance reminder date.
• Confirm the applicant’s legitimacy: verify the Article 11 requirements separately for the self-manufacturing route and the licensed business operator route.
• Build the post-market obligation mechanisms in parallel: the six obligations of Article 16 cannot wait until after the certificate is obtained.
• Work through the exemption list first: custom-made devices, personal use, Hengqin manufacture and similar situations are excluded first.
• Schedule premises and manufacturing plants separately under Articles 66 and 67: do not merge their timelines with the product timeline.

5. Verification checklist

• □ It has been confirmed that the regime takes effect on 1 July 2026 (law and Implementation Rules simultaneously)
• □ The product attribute and risk class inventory of all SKUs is complete
• □ For every SKU it has been determined whether the transitional arrangements of Article 65 apply
• □ Reminder dates for applying at least one year before expiry of the transitional period are set
• □ The applicant’s legitimacy (Article 11) has been verified
• □ Timelines for existing premises (Article 66) and existing manufacturing plants (Article 67) are scheduled separately
• □ The exemption list (Article 9(3), Article 8, and Chief Executive Dispatch No. 142/2026) has been reviewed
• □ Work on the six post-market obligations of Article 16 has started

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