Applicant Eligibility for Medical Device Registration under Article 11

1. Key takeaways

Article 11 of Law No. 12/2025 divides applicants into 2 categories:

• Applicants that manufacture by themselves or through commissioning (paragraph 1): they must simultaneously satisfy 4 requirements — a natural person domiciled in Macao, China or a legal person duly established in Macao, China; not being within a period of supplementary penalty, supplementary punishment or security measure prohibiting engagement in medical device business activities; not being within a period prohibiting application for registration or notification; and having no debt currently subject to compulsory enforcement through tax enforcement proceedings.
• Applicants importing devices already registered or granted marketing authorisation outside Macao (paragraph 2): for Class I and Class IIa devices, a foreign trade operator meeting the requirement on clean status described above; for Class IIb and Class III devices, a medical device trading licence holder engaged in import, export and wholesale activities (or an establishment holding a licence for the import, export and wholesale of pharmaceutical products, or a licence for the import, export and wholesale of Chinese medicine).

Applicant eligibility cannot be remedied after the fact — this is the least recoverable point of failure in the entire process.

2. Legal basis

Applicant eligibility for both manufacturing and import scenarios is governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: an overseas manufacturer can act as its own applicant, but it must first have a Macao entity. Article 11(1) allows natural or legal persons that manufacture by themselves or through commissioning, inside or outside the Macao Special Administrative Region of China to apply, provided that the legal person is duly established in Macao, China. In other words, once an overseas parent company establishes a subsidiary in Macao, that subsidiary holds applicant eligibility, and there is no need to route the application through a third party.

Insight 2: under the import pathway, entity requirements are tiered by risk class. Class IIb and Class III devices must be applied for by a trading licence holder, which is a higher threshold; Class I and Class IIa devices may be notified by a foreign trade operator alone. This explains why market access in Macao is markedly faster for low-risk products — the entity threshold itself is lower.

Insight 3: 2 of the 4 requirements are clean-status requirements. The requirements of not being within any prohibition period and having no debt in tax enforcement proceedings require the submission of a criminal record certificate and a certificate of no debt issued by the Finance Services Bureau. Where an overseas parent company appoints its Macao subsidiary to apply, the managers and members of the administrative body of that subsidiary must likewise submit criminal record certificates (Article 11(3)).

Insight 4: holding a licence exempts part of the documentation. Article 10(3) of the Implementing Rules provides that an applicant holding a manufacturing licence or a trading licence need not submit the documents under items (1) to (3) of paragraph 2 (applicant information, criminal record certificate and certificate of no debt). Obtaining the licence first and then applying for registration can save an entire set of administrative documents.

4. Practical recommendations

• Fix the entity before fixing the pathway: complete the establishment of the Macao entity or the application for the trading licence before starting dossier preparation.
• Prioritise licence-holder status: it exempts 3 categories of administrative documents from the registration application and reduces the risk of deficiency corrections.
• Obtain the criminal record certificate early: the purpose stated on the application must be specified as an application relating to medical device registration or notification, and the Identity Services Bureau can send it directly to ISAF.
• Obtain the certificate of no tax debt in parallel: it is issued by the Finance Services Bureau and is one of the non-remediable eligibility requirements.

5. Verification checklist

• □ It has been confirmed whether the case falls under Article 11(1) (self-manufacture) or Article 11(2) (import)
• □ The Macao entity (legal-person establishment or natural-person domicile) has been secured
• □ Criminal record certificates have been obtained (including for managers and members of the administrative body)
• □ The certificate of no debt from the Finance Services Bureau has been obtained
• □ For imported Class IIb and Class III devices, trading licence holder status has been confirmed
• □ The option of obtaining a licence first in order to exempt part of the registration documents has been assessed

Regulatory information verified as of 29 October 2026. The regulations, 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 subsequently 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 applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com