Mandatory Circulation and Statutory Exemptions in Macao, China

1. Key takeaways

Article 9(1) of Law No. 12/2025 provides that only medical devices registered or filed under the regime may circulate in Macao, China. Paragraph 3 of the same article lists the situations to which the registration and filing regime does not apply, which the official publicity materials summarise as five categories: (1) devices manufactured or imported by order or with the approval of ISAF in response to a public health emergency and a shortage of medical devices; (2) devices for use solely in research and clinical trials; (3) samples used for constituting a registration dossier or a filing record; (4) devices displayed solely within academic conferences or exhibition events; and (5) devices needed for the treatment or diagnosis of the special condition of a specific patient. Exemption does not mean free rein — devices imported from outside still require an import licence.

The five categories are narrow and each is defined by purpose of use rather than by device type. Research devices, dossier samples and exhibition units are tied to the specific use declared at import; the public health emergency category depends on an order or approval of ISAF; and the patient-specific category is confined to the treatment or diagnosis of the special condition of the particular patient for whom the device is supplied. Because the exemption attaches to the declared purpose, any departure from that purpose removes the exemption, and the device must then be registered or filed before it can continue to circulate lawfully.

2. Legal basis

The mandatory circulation rule and its exemptions derive from the following provisions of the law, the implementing regulation and the foreign trade legislation.

3. Expert insights

Insight 1: Exemption means exemption from registration and filing, not from all obligations. The authorities make clear that devices exempted from registration and filing must still comply with the statutory requirements (for example, devices imported from outside require an import licence). The import licence requirement under Law No. 7/2003 operates independently of the device regime, so clearing the device rules never clears the trade rules. Companies often read exemption as meaning that nothing needs to be done at all; this is the most dangerous misreading of the regime.

Insight 2: Three of the exemption categories require an approval application to ISAF. Article 26 of the implementing regulation provides that applications for approval under subparagraphs (1) to (5) and (7) of Article 9(3) must be submitted on the dedicated form, accompanied by a statement and supporting documents, specimens of labels and instructions for use, a declaration of responsibility for adverse event monitoring (in some cases) and proof of overseas marketing (in some cases). Exemption must be applied for; it is not enjoyed automatically.

Insight 3: Research and clinical trial use and the market pathway are two separate lines. Devices for clinical trials follow the prior licensing procedure under Dispatch No. 4/ISAF/2026 and do not go through registration; once the purpose of the trial changes to supplying the market, the device must return to the registration or filing pathway.

Insight 4: Custom-made medical devices are the only category exempt even from the import licence. Article 8(3) provides that the import of custom-made medical devices does not require the import licence under Law No. 7/2003, and custom-made devices are exempt from registration and filing. This is the most exceptional treatment in the entire regime (see the dedicated article on custom-made medical devices).

4. Practical recommendations

• First determine whether the exemption genuinely applies: each of the five categories has boundaries, and a device imported for display alone loses the basis of its exemption the moment a sale takes place; a written determination of the applicable category, kept on file, is the first line of defence in any later enquiry.
• Apply even when exempt: submit the dedicated form and supporting documents under Article 26 of the implementing regulation; do not import directly on the ground that the law provides an exemption.
• Keep the import licence ready for exempt devices: for devices imported from outside, proceed under Law No. 7/2003.
• Reassess immediately upon any change of use: a shift from research use to commercial supply, or from sample to sale, requires the device to go through registration or filing again.

5. Verification checklist

• □ Confirmed under Article 9(1) that the product must be registered or filed
• □ The five exemption categories of Article 9(3) compared one by one
• □ For exempt devices, application submitted under Article 26 of the implementing regulation
• □ Import licence obtained for exempt devices imported from outside
• □ Reassessment mechanism for changes of use established
• □ Quantities and destinations for exhibition, sample and research uses archived for inspection

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