Manufacturing Licence for Medical Devices in Macao, China

1. Key takeaways

Manufacturing medical devices in Macao, China requires a manufacturing licence under Article 32 of Law No. 12/2025. The licence is valid for 3 years and may be renewed for the same period (Article 33). The implementing rules contain one important business facilitation measure: applicants for a manufacturing licence may submit their application while still holding a provisional industrial licence, so as to shorten the time needed to obtain the licence. The application must be submitted on a dedicated form (stating the applicant, the name and address of the manufacturing plant, the number and date of issue of the industrial licence, the products to be manufactured, and the name of the technical director to be engaged) together with 12 categories of supporting documents, among which the quality management system documentation for the manufacturing activities is the core element.

• A manufacturing licence is mandatory for manufacturing medical devices in Macao, China.
• The licence is valid for 3 years and may be renewed for the same period.
• Applications may already be filed at the provisional industrial licence stage.
• A dedicated form and 12 categories of attachments must be prepared.
• Quality management system documentation is the core technical file.
• Renewal requires an on-site verification of compliance with good manufacturing practice.

2. Legal basis

The legal framework for the manufacturing licence consists of the parent law, the implementing rules, a technical dispatch on quality management system documentation, and the fee schedule approved by the Chief Executive. The table below summarises the instruments relied on in this article, together with the specific provisions cited.

3. Expert insights

Insight one: the manufacturing licence involves parallel review by several departments, not approval by the ISAF alone. The implementing rules provide that the ISAF forwards the application to the Environmental Protection Bureau on the working day immediately following receipt; the Environmental Protection Bureau issues a binding opinion within its remit within 30 working days, and the ISAF prepares a report and makes a decision within 30 working days from the date on which the information is complete and the opinion is received. These two segments alone account for approximately 60 working days (practical estimate, excluding corrections).

Insight two: an inspection stage sits between approval of the plans and issue of the licence. Once the plans are approved, the applicant must apply for inspection after the premises, facilities and equipment have been installed, within one year from receipt of the notification (one extension of the same period may be requested); the ISAF conducts the inspection jointly with the Environmental Protection Bureau within 15 working days from receipt of the application; the inspection record is drawn up within 20 working days from completion of the inspection. If the one-year time limit is not observed, the approval lapses.

Insight three: information on the technical director may be submitted later. The implementing rules provide that the information on the technical director to be engaged may be submitted after the premises pass the inspection. This is a pragmatic arrangement — companies do not have to lock in their choice of technical director at the early stage of the application.

Insight four: renewal of the manufacturing licence requires an on-site inspection of compliance with GMP. The renewal provisions expressly state that, for the purpose of renewing a manufacturing licence, the ISAF shall inspect the medical device manufacturing plant to verify whether it complies with the applicable good manufacturing practice requirements. Renewal is not a formality-only re-issuance.

4. Practical recommendations

• File the application already at the provisional industrial licence stage: this can materially shorten the overall timeline; do not wait until the definitive industrial licence has been obtained.
• Engage with the Environmental Protection Bureau in parallel: its opinion is a binding upstream step, so engineering plans should take environmental requirements into account from the outset.
• Prepare the quality management system documentation in accordance with Dispatch No. 22/ISAF/2026: this is the core technical document of the application.
• Build the one-year inspection application deadline into the project schedule: missing it causes the approval to lapse and the earlier investment to be wasted.
• Plan renewal in the 90 to 180 day window before expiry: this window is the same as the product registration renewal window, so both can be managed together.

5. Verification checklist

• □ Confirmed that a manufacturing licence is required (manufacturing medical devices in Macao, China)
• □ Application filed at the provisional industrial licence stage
• □ Dedicated form and 12 categories of attachments completed
• □ Quality management system documentation prepared in accordance with Dispatch No. 22/ISAF/2026
• □ Timeline planned for the Environmental Protection Bureau opinion (30 working days) and the ISAF decision (30 working days)
• □ Inspection application submitted within one year after approval of the plans
• □ Renewal scheduled 90 to 180 days before expiry

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