Custom-Made Medical Devices in Macao, China: Exemptions and Obligations

1. Key takeaways

Custom-made medical devices receive the most distinctive treatment in the Macao regime: Article 8(3) of Law No. 12/2025 provides that the import of custom-made medical devices does not require an import licence under Law No. 7/2003 on Foreign Trade; and Article 9 of the same law, together with the official publicity materials, makes clear that custom-made medical devices are exempt from registration and notification. This means that custom-made devices in Macao are relieved of both product access and import licensing requirements — but this does not mean they are exempt from the rules governing manufacturing: custom-made dentures are subject to a dedicated production quality management specification (Dispatch No. 17/ISAF/2026), and local manufacturing also engages the manufacturing licence and transitional arrangements.

• The exemptions cover product access and import licensing, not manufacturing standards.
• The core of the custom-made judgement is patient-specific design input.
• The import licence exemption of Article 8(3) is narrow and cannot be applied by analogy to other situations.
• Custom-made devices are not separately listed in the transitional arrangements, so their transition priority is lower than that of registrable products.
• Import needs no import licence, but the customisation basis — prescriptions, design input and patient-matching records — must be fully archived for inspection by ISAF.

2. Legal basis

The import licence exemption, the registration exemption and the manufacturing rules for custom-made devices are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: what is exempted is product access and import licensing, not manufacturing standards. The regime has issued a dedicated production quality management specification for custom-made dentures (Dispatch No. 17/ISAF/2026), which shows that custom-made devices remain subject to GMP requirements. Where manufacturing takes place within Macao, China, the manufacturing licence (Articles 32 and 33) and the transitional arrangements of Article 65 are also engaged.

Insight 2: the core of the custom-made judgement is patient-specific design. The distinction between a custom-made device and a mass-produced device offered in multiple sizes lies in whether there is design input targeting a specific patient, documented as such before production. Merely selecting a size from existing models does not make a device custom-made (a practical estimate; the actual determination rests with ISAF).

Insight 3: the import licence exemption in Article 8 is narrow. Article 8 contains 3 paragraphs of exemptions: Class I and Class IIa devices for personal use whose value does not exceed the amount set out in a dispatch (MOP 5,000); devices carried on vehicles, vessels, aircraft or other public transport for medical rescue during the journey; and custom-made medical devices. The three apply to entirely different subjects and cannot be applied by analogy. A device that falls outside all three situations still requires an import licence in the ordinary way, and the exemption relied upon must be identified precisely before import.

Insight 4: the transitional arrangements do not separately address custom-made devices. Articles 65 to 67 deal respectively with manufacturers, premises and devices already on the market, without mentioning custom-made devices (because they are exempt from registration and notification in the first place). This suggests that in transition-period planning, custom-made products may be given a lower priority than products requiring registration.

4. Practical recommendations

• Confirm first that the device is genuinely custom-made: use the presence of patient-specific design input as the criterion and record the judgement in a written determination.
• Prepare local manufacturing against the GMP and licence requirements: establish the quality management system for custom-made dentures in accordance with Dispatch No. 17/ISAF/2026.
• Import needs no import licence, but the customisation basis must be retained: medical prescriptions, design input and patient-matching records should be fully archived for inspection by ISAF.
• Do not use the custom-made label to evade registration: disguising a mass-produced product as custom-made is circumvention and may trigger a risk assessment under the offence concerning counterfeit medical devices in Article 51 (a practical estimate), with consequences to be assessed by ISAF.

5. Verification checklist

• □ The custom-made judgement has been completed on the criterion of patient-specific design input
• □ It has been confirmed that import requires no import licence (Article 8(3))
• □ It has been confirmed that the device is exempt from registration and notification (Article 9)
• □ For local manufacturing, the GMP system has been established under Dispatch No. 17/ISAF/2026
• □ The customisation basis (medical prescriptions, design input, patient-matching records) has been archived
• □ It has been confirmed that the case is not one of evading registration through the custom-made label

Regulatory information verified as of 29 October 2026. The regulations, 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 subsequently 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 applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com