Import Licence and Foreign Trade Law Exemptions in Macao

1. Key takeaways

Macao, China operates an import licence regime for medical devices, which connects to Law No. 7/2003, the Foreign Trade Law. Article 8 of Law No. 12/2025 sets out the situations in which the import licence is waived; the most operationally valuable one for companies is that Class I and Class IIa medical devices for personal use with a value not exceeding MOP 5,000 do not require an import licence. In addition, medical devices used on land, maritime or air transport vehicles and custom-made medical devices are also among the exemptions. An exemption from the import licence is not an exemption from registration or filing — apart from the statutory exemptions, devices must still complete registration or filing before they can be placed on the market.

• Import of medical devices into Macao, China is subject to an import licence regime linked to the Foreign Trade Law.
• Class I and Class IIa devices for personal use valued at up to MOP 5,000 are exempt.
• Devices used on land, maritime or air transport vehicles are exempt.
• Custom-made devices are exempt from both registration and filing and from the import licence.
• Exemption from the import licence never substitutes for registration or filing.

2. Legal basis

The import control framework connects the medical device law with the foreign trade regime and a Chief Executive dispatch on import licence matters. The table below lists the instruments and provisions cited in this article.

3. Expert insights

Insight one: MOP 5,000 is a value threshold, not a quantity threshold. The structure of the provision requires three conditions to hold simultaneously: personal use, a value not exceeding MOP 5,000, and Class I or Class IIa classification. This means that even a single item falls outside the exemption if its unit price exceeds MOP 5,000; conversely, several items whose combined value exceeds MOP 5,000 also exceed the scope of the exemption. Practical estimate: customs and the ISAF judge whether a given batch constitutes personal use by looking at quantity, packaging and purpose together; bulk purchasing does not qualify for the exemption.

Insight two: the scope of the exemption is drawn by risk classification, and Class IIb and Class III do not qualify. The legislator included only Class I and Class IIa devices in the personal-use exemption; Class IIb and Class III devices are not covered by it regardless of value or whether they are for personal use. This coincides exactly with the dividing line of the dual registration and filing track — risk classification is the thread that runs through the entire regime in Macao, cutting across everything from procedure selection to import control.

Insight three: the exemption for devices used on transport vehicles is a functional exemption. Medical devices used on land, maritime or air transport vehicles are exempt from the import licence; the rationale is that such devices serve the operation and safety of the transport vehicle itself and are not placed on the local market. Cross-border logistics, aviation and shipping suppliers are the main beneficiaries of this provision, but once a device is removed and sold separately, it leaves the premises of the exemption.

Insight four: custom-made devices are exempt from both registration and filing and the import licence. Law No. 12/2025 excludes custom-made medical devices from mandatory registration and filing, and also does not require an import licence at the import stage. This is a rare double exemption in the regime, but the price is that a custom-made device must strictly meet the definition of custom-made — individually made to specific medical prescriptions for a specific user, and not a variant of mass production.

Insight five: the import licence and foreign trade operator status are two different matters. The exemption answers whether an import licence is needed; the foreign trade operator answers who is qualified to engage in foreign trade activities. When designing the import structure, companies must not ignore the foreign trade operator registration requirement merely because an exemption has been obtained — these are two independent dimensions of compliance.

4. Practical recommendations

• Test the conditions for the exemption shipment by shipment: verify personal use, value and risk classification item by item and keep the supporting documents.
• Do not use the personal-use exemption for Class IIb and Class III devices: plan them exclusively through the regular import licence route.
• Write the MOP 5,000 threshold into e-commerce and sample shipment SOPs: cross-border samples and exhibition samples easily cross the line.
• Secure foreign trade operator status first: confirm the status of the subject before negotiating the import licence.
• Distinguish exemption from the import licence from exemption from registration or filing: neither substitutes for the other.

5. Verification checklist

• □ Risk classification of the device confirmed (Class I, IIa, IIb or III)
• □ Value of the shipment confirmed as not exceeding MOP 5,000
• □ Confirmed that the shipment is for personal use and not a commercial batch
• □ Confirmed whether the device is used on a transport vehicle or is custom-made
• □ Foreign trade operator status confirmed as in place
• □ Confirmed whether the device has completed registration or filing
• □ Written record of the exemption assessment retained for reference

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