The Four Risk Classes of Medical Devices in Macao, China

1. Key takeaways

Macao, China classifies medical devices into four classes: Class I (low risk), Class IIa (medium-low risk), Class IIb (medium-high risk) and Class III (higher risk). The classification basis is the Catalogue of Classification of Medical Devices of the Macao Special Administrative Region approved by Dispatch No. 36/2026 of the Secretary for Social Affairs and Culture, while the classification rules and technical requirements are set out in Dispatch No. 1/ISAF/2026. Classification decides three things: whether the device takes the filing or the registration pathway, whether a licence is required, and whether retail sale is possible.

The class determination is therefore the single most consequential compliance decision a manufacturer makes for the Macao market. It is recorded in the device overview required for the dossier, it drives the choice between the filing pathway of Article 24 and the registration pathway of Article 17, and it determines whether a retail channel is legally available at all. Because the catalogue is an approved annex and the rules sit in an ISAF dispatch, the two sources must be read together: the catalogue answers the typical case quickly, while the rules of Dispatch No. 1/ISAF/2026 govern devices whose features place them outside the listed entries.

2. Legal basis

The classification framework rests on the law, the approved catalogue and the ISAF dispatch setting out the classification rules, as listed below.

3. Expert insights

Insight 1: The official example table is the fastest reference frame for class determination. The ISAF publicity materials list the classification of common devices as follows.

• Class I: fever-reducing patches, adhesive wound dressings, medical cotton swabs, bandages and gauze, crutches, wheelchairs and powered wheelchairs, condoms (without drugs)
• Class IIa: electronic thermometers, blood pressure monitors, blood glucose meters, nasal saline rinse solutions, pregnancy test sticks, syringes and injection needles, wearable hearing aids
• Class IIb: haemodialysis equipment, facial fillers, insulin injection pens, condoms (with drugs), SARS-CoV-2 antigen rapid test reagents
• Class III: coronary stents, implantable cardiac pacemakers, human immunodeficiency virus (HIV) antigen/antibody detection reagents, artificial cervical discs, artificial knee joints, automated external cardiac defibrillators (AED), cochlear implants

Insight 2: With drugs versus without drugs changes the class. Condoms without drugs are Class I, while condoms with drugs are Class IIb. This shows that classification in Macao, China examines whether the device contains pharmacologically active ingredients — an approach close to Rule 21 of the EU MDR, and a determination variable that mainland manufacturers often overlook. A formulation change that adds a pharmacologically active ingredient can therefore move a product across classes, and the classification determination must be revisited whenever the composition changes.

Insight 3: The classification catalogue can be adjusted. Article 7 is dedicated to the adjustment of the classification rules and the classification catalogue, which shows that the catalogue is not a static list and that ISAF retains the power to adjust it. Companies should archive the classification determination together with the date of the determination and the version of the basis used, which also protects the company if the catalogue is later adjusted.

Insight 4: Classification directly determines commercial reachability. Class III devices are prohibited from retail sale and may only be supplied to medical institutions such as hospitals and clinics, and to scientific research institutions. This means the sales channels for higher-class products are legally constrained, regardless of how marketable the product is.

4. Practical recommendations

• Check the catalogue first, then apply the rules: where the catalogue has an explicit entry, determine by the catalogue in priority; where the catalogue does not cover the device, determine under the classification rules of Dispatch No. 1/ISAF/2026.
• Pay particular attention to three variables: with or without drugs, invasiveness, and duration of action: in the official examples these variables repeatedly serve as the dividing line across classes.
• Archive the determination conclusion: record the date of the determination, the version of the catalogue used and the rule provisions applied, as evidence for later disputes and tenders.
• Design the channel early for higher-class products: Class III devices are prohibited from retail sale, so the business plan should be built around supply to medical institutions.

5. Verification checklist

• □ Corresponding entry found in the Catalogue of Classification of Medical Devices of the Macao Special Administrative Region
• □ Devices not covered by the catalogue determined under the rules of Dispatch No. 1/ISAF/2026
• □ Cross-class variables such as pharmacologically active ingredients checked
• □ Classification determination archived (with date and version)
• □ Pathway (filing/registration), licence requirement and retail restrictions confirmed by class
• □ Channel for Class III products designed on the basis of the retail prohibition

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