Definition of a Medical Device in Macao, China

1. Key takeaways

Whether a product is a medical device is the first fork in every compliance route. The definition is set out in Article 2 (definitions) of Law No. 12/2025, and the scope of the law in Article 1 (scope). The official publicity materials summarise device purposes as the prevention, diagnosis, treatment and rehabilitation of disease, and expressly include the provision of information for medical or diagnostic purposes through the examination of samples taken from the human body — this sentence is precisely the legal basis on which in vitro diagnostic reagents fall within the device category. The examination-of-samples clause is also the reason blood screening reagents appear among the official high-class examples. A determination error propagates downstream: wrong class, wrong pathway, wrong applicant entity.

The definition therefore works as a gateway test. A product that meets the device definition enters the classification system of Article 6 and the classification catalogue approved by Dispatch No. 36/2026 of the Secretary for Social Affairs and Culture; a product that does not is outside the regime altogether, subject only to whatever other rules govern its category. Because the intended use stated in the device overview drives the class, the same physical product can land in different classes when its claimed purpose differs, which is why the purpose statements across the instructions for use, the labelling and the promotional materials must be aligned before the dossier is assembled, since a mismatch invites a classification challenge.

2. Legal basis

The definition and scope analysis rests on the following provisions and published materials.

3. Expert insights

Insight 1: The definition includes pregnancy control. In listing device purposes, the official publicity materials expressly include pregnancy control. This means that contraceptive products fall within this regime as long as they meet the device definition — condoms are listed in the official examples as Class I (without drugs) and Class IIb (with drugs), a direct illustration of this definition.

Insight 2: In vitro diagnostic reagents are not regulated by a separate law but managed uniformly as devices. The regime does not legislate separately for IVDs; it brings them into the device classification system. However, manufacturing has its own GMP technical instruction — Dispatch No. 20/ISAF/2026, the Good Manufacturing Practice for In Vitro Diagnostic Reagents. This structure of uniform management with differentiated measures runs in the same direction as the approaches of the Chinese mainland and the European Union.

Insight 3: In vitro diagnostic reagents can sit in a very high class. In the official examples, human immunodeficiency virus (HIV) antigen/antibody detection reagents are Class III, SARS-CoV-2 antigen rapid test reagents are Class IIb, and pregnancy test sticks are Class IIa. The same technology platform (immunochromatography) spans three classes depending on the intended use of the test — this is where IVD classification is most easily misjudged.

Insight 4: Intended use is the core input of the definition. The device overview required by the implementing regulation includes model or specification, class, performance, main structural composition or ingredients, mechanism of action, intended use and scope of application. Once the intended use is written down, it simultaneously binds classification, labelling and subsequent promotion, and all three must remain consistent; any later change to the claimed purpose must be reflected in all three at the same time.

4. Practical recommendations

• Fix the intended use before starting the determination: the statements of use in the instructions for use, the labelling and the promotional materials must first be aligned.
• Classify IVDs by testing purpose, not by technology platform: first clarify the analyte and the use scenario (self-testing, professional use, blood screening), then consult the classification catalogue.
• Take borderline products to pre-procedure consultation: for products on the drug-device boundary or the device-cosmetic boundary, consult ISAF before investing in dossier preparation.
• Prepare GMP documentation separately for IVDs: where local manufacturing is involved, prepare the quality management system documentation under Dispatch No. 20/ISAF/2026.

5. Verification checklist

• □ Product confirmed as a medical device under the definition in Article 2
• □ Statements of intended use consistent across instructions for use, labelling and promotional materials
• □ IVD products classified by testing purpose in the catalogue (not by technology platform)
• □ Confirmed whether the case of providing information through examination of human samples applies
• □ Pre-procedure consultation completed for borderline products and opinions retained
• □ For local manufacturing, documentation prepared under the corresponding GMP technical instruction

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