Contract Manufacturing Permit in Macao, China

1. Key takeaways

Article 36 of Law No. 12/2025 governs contract manufacturing. The implementing rules provide that an application for a contract manufacturing permit must be submitted on a dedicated form (stating the contracting party, the contracted party, the name and address of the manufacturing plant, and the types and names of the devices to be manufactured under the contract) together with 4 categories of attachments (applicant information, a statement or proof of the legitimacy of the contracting party, a draft contract, and information proving that the contracted party is capable of performing the relevant manufacturing processes). The ISAF shall complete the review within 35 working days from receipt of the application; the permit is valid for 3 years, but may not exceed the term of the contract concluded between the contracting party and the contracted party.

• Contract manufacturing in Macao, China is regulated by Article 36 of Law No. 12/2025 and the implementing rules.
• The application consists of a dedicated form and 4 categories of attachments.
• The ISAF reviews the application within 35 working days.
• The permit is valid for 3 years, capped by the term of the manufacturing contract.
• Renewal requires production and quality summaries and, where available, reports of overseas on-site inspections.
• Termination of the contract leads directly to cancellation of the permit.

2. Legal basis

The framework consists of the parent law, the implementing rules, a technical dispatch on applications for the permit, and the fee schedule. The table below lists the instruments and provisions cited in this article.

3. Expert insights

Insight one: the cap at the term of the contract is the key limitation. The permit is valid for 3 years, but its term is capped at the validity of the manufacturing contract. If the contract is signed for only 2 years, the permit can last at most 2 years as well (practical estimate, subject to confirmation by the ISAF). When negotiating a manufacturing contract, companies should consider the contract term and the permit term together.

Insight two: the decision is due within 20 working days, but there are two possible starting points. The implementing rules provide that the president of the ISAF shall decide within 20 working days from the date on which the information required for the application is complete or from the date of the notification of the result of the final inspection. Whether an inspection is initiated therefore directly determines the starting point.

Insight three: the renewal dossier includes overseas inspection reports. Renewal must be accompanied by: a declaration that the contracted party still meets the manufacturing conditions; a summary of production and quality status (covering the devices produced, the quality review analysis, and corrective and preventive actions); the information proposed to be updated; and a copy of the report or record of an on-site inspection of the contracted party by a competent authority or body outside the Macao Special Administrative Region (where no such inspection has taken place, a declaration is submitted instead). This is a rare proactive disclosure obligation within the regime.

Insight four: cancellation and lapse each have four and two situations respectively. Cancellation situations include: application by the contracting party; the contracting party no longer having legitimacy, or the contracted party no longer meeting the manufacturing conditions and failing to correct within the set period; termination of the manufacturing contract; and obtaining the permit by false means. Lapse situations are failure to apply for renewal on time and non-renewal of the permit. Termination of the manufacturing contract leads directly to cancellation of the permit.

Insight five: Article 65(6) opens a door for manufacturers in the transitional period. For contracted parties under manufacturing contracts concluded by medical device manufacturing plants in a transitional situation, the provisions of Article 36(3)(3) do not apply. This forms part of the transitional arrangements.

4. Practical recommendations

• Align the contract term with the permit term: avoid a contract shorter than 3 years compressing the duration of the permit.
• Plan around the 35 working day review period: and reserve additional time for a possible inspection.
• Prepare renewal documents early: in particular the production and quality summary and the overseas on-site inspection reports.
• React immediately upon contract termination: the permit will be cancelled, and the manufacturing arrangements must be re-planned.

5. Verification checklist

• □ Dedicated form and 4 categories of attachments completed
• □ Review period scheduled on the basis of 35 working days
• □ Term of the manufacturing contract aligned with the 3-year permit term
• □ Renewal documents (production and quality summary, overseas inspection reports) planned
• □ The four cancellation situations and the two lapse situations understood
• □ Manufacturers in the transitional period confirmed the applicability of Article 65(6)

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