ISAF: The Medical Device Regulator and Its Scope in Macao, China

1. Key takeaways

Law No. 12/2025 designates the Drug Administration Bureau (ISAF) as the regulatory authority for medical devices in Macao, China. The handling unit for external affairs is the Registration Division — Division of Chemical Drugs, Biological Drugs and Medical Devices, located on the 19th floor of the Government (Qingmao) Office Building on Avenida do Comendador Ho Yin, Macao, telephone (853) 2883 1906, fax (853) 2883 1905, e-mail dmqbdm@isaf.gov.mo. The law also establishes a dedicated committee (Article 10) to provide professional technical opinions on registration applications; its composition and operation are set out in the implementing regulation: it consists of an odd number of professionals, at least 11 members, with a term of office of at most three years, renewable. All correspondence, dossier submissions and inspection arrangements for medical devices run through the handling unit, so fixing the correct contact details at the start of a project avoids misdirected submissions that delay review.

2. Legal basis

The institutional framework, the contact channels and the inspection powers described above are grounded in the following instruments and published materials.

3. Expert insights

Insight 1: ISAF is a combined agency for drugs and devices. Macao, China places medicines and medical devices under the same bureau, a direction consistent with Hong Kong, China (the Medical Device Division of the Department of Health) and the Chinese mainland (the National Medical Products Administration), but the internal divisions are already clearly separated — the Division of Chemical Drugs and Devices under Administrative Regulation No. 35/2021 has been formally renamed the Division of Chemical Drugs, Biological Drugs and Medical Devices. The name change reflects an expansion of functions: an upgrade from the registration of small devices to the registration and filing of medical devices.

Insight 2: The dedicated committee underpins technical review and is a mandatory step for innovative devices. Article 10 establishes the dedicated committee; the implementing regulation further specifies that it consists of at least 11 members in an odd number, with a term of office of at most three years. For innovative medical devices, the President of ISAF must seek the opinion of the committee before making the registration decision; the only exception is where the applicant has already submitted an evaluation report from a reputable third-party technical review body — this exception mechanism is the core design of the innovative device pathway.

Insight 3: ISAF has a duty to proactively publish information. Article 5 provides for the publication of information, and the public can consult the details of registered or filed medical devices on the ISAF website. This means the listed information is publicly verifiable; purchasers and competitors alike can look it up, so the accuracy of the data carries external binding force.

Insight 4: Inspectors are backed by real inspection powers. Article 48 provides for inspectors, and the implementing regulation further specifies the conditions for launching inspections of development sites and manufacturing sites, the notification time limit (notice given at least 10 working days before the date of the inspection) and the requirements for written records. This is a regulatory system with substantive inspection capability, not a purely documentary review.

4. Practical recommendations

• Fix a single point of contact: use the Registration Division — Division of Chemical Drugs, Biological Drugs and Medical Devices as the sole external window, and keep a documented record of all written enquiries.
• Make use of the published information under Article 5: before submitting, search the ISAF website for registered or filed products in the same category; existing naming and classification of comparable devices can serve as a reference for your determination.
• Arrange third-party evaluation early for innovative devices: if the innovative pathway is planned, first confirm that the evaluation body is on the list in Dispatch No. 15/ISAF/2026.
• Pre-establish an inspection cooperation procedure: manufacturing and business premises must be able to produce records and written procedures at any time, and the notice period for an inspection is only 10 working days.

5. Verification checklist

• □ ISAF handling unit, address, telephone and e-mail recorded
• □ Role of the dedicated committee under Article 10 and the composition rules of Administrative Regulation No. 11/2026 understood
• □ Registered or filed products in the same category searched on the ISAF website
• □ Confirmed whether the third-party evaluation body for innovative devices is on the list
• □ Inspection cooperation procedure established (10 working day notice period)
• □ Records of external correspondence archived

Regulatory information verified as of October 29, 2026. The regulations, guidance 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 have been 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 procedures, prepares Portuguese/Chinese-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com