Technical Director Requirements in Macao, China

1. Key takeaways

Article 41 of Law No. 12/2025 establishes the technical director regime. The implementing rules add two public disclosure obligations: premises engaged in the retail of Class IIb medical devices must display a notice board in a conspicuous place stating the name of the technical director and, where applicable, the number of the medical practitioner licence; and the technical director must wear an identification badge bearing the same information and the name of the premises. In addition, where the licence holder changes its manager, members of the administrative body or holders of the principal positions of its organs, the ISAF shall review within 15 working days from the date on which the information is complete whether the proposed appointee meets the requirements.

• The technical director is a person-based compliance requirement running alongside product compliance.
• Manufacturing licence applications must already name the proposed technical director.
• Technical director information may be submitted after the premises pass the inspection.
• The notice board and identification badge obligations apply only to Class IIb retail premises.
• Changes of manager or senior office holders are subject to review within 15 working days and a fee of MOP 300.

2. Legal basis

The regime rests on Article 41 of the parent law, on the identification and change-of-personnel provisions of the implementing rules, and on the fee schedule approved by the Chief Executive. The table below lists the instruments and provisions cited.

3. Expert insights

Insight one: the technical director is compliance of a person, running in parallel with compliance of the product. The regime requires the manufacturing licence application to state the name of the technical director to be engaged, accompanied by a copy of identity documents, proof of education and work experience, the criminal record certificate, and a declaration of taking up the post. This is a regime with a human resources threshold, not a purely documentary one.

Insight two: technical director information may be deferred until after the premises pass the inspection. The implementing rules provide that the information on the technical director in the manufacturing licence application may be submitted after the premises pass the inspection. This gives companies a recruitment buffer, but it also means that a personnel confirmation step remains between passing the inspection and issue of the licence.

Insight three: the notice board and identification badge apply only to Class IIb retail. Retail of Class I and Class IIa devices requires no business licence and carries no such disclosure obligation; retail of Class III devices is prohibited. The scope of this obligation is precisely limited to Class IIb retail premises — a provision that is easily over-applied. Companies operating mixed portfolios should check each premises separately against the classification of the devices actually retailed there, instead of applying the display duties uniformly across the network.

Insight four: personnel changes carry both a review period and a fee. Changing the manager, members of the administrative body or holders of the principal positions of the organs requires submission of a copy of the identity documents and the criminal record certificate of the proposed appointee; the ISAF reviews within 15 working days, and the fee is MOP 300 under item 4.6 of Table 1 of the fee schedule. Personnel changes are not an internal matter; they must be reported to the ISAF for review. Because the review clock starts only once the information is complete, submitting an incomplete set of documents does not start the period and simply delays the appointment.

4. Practical recommendations

• Start looking for a technical director early: proof of education and work experience are hard documents, and the recruitment lead time should be built into the project plan.
• Prepare the notice board and identification badge in parallel for Class IIb retail premises: the format and content must follow the requirements of the implementing rules.
• Report personnel changes with 15 working days to spare: this avoids vacancy gaps caused by the review period.
• Keep technical director records on file: centralise the appointment, education, experience, criminal record and post declaration documents for retrieval during inspections.

5. Verification checklist

• □ Technical director identified in accordance with Article 41
• □ Identity, education, work experience, criminal record and post declaration documents of the technical director completed
• □ Notice board installed at Class IIb retail premises
• □ Identification badge of the technical director produced and worn
• □ Personnel change planned with the 15 working day review period and the MOP 300 fee
• □ Technical director records filed and available for inspection

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