Quality Standards and Chinese National Standards (GB) in Macao, China

1. Key takeaways

Article 12 of Law No. 12/2025 requires medical devices to satisfy four requirements simultaneously: compliance with quality standards; effectiveness; safety (presenting no danger to human health under conditions of normal use); and a name, labelling and instructions for use that comply with the law and its supplementary regulations. For the quality standards requirement, the order of determination is: (1) the mandatory national standards of China for medical devices, or standards established by the competent authorities of a country or region recognised by ISAF or by organisations recognised by them; (2) where no such standards exist, other standards submitted by the applicant and recognised by ISAF. ISAF may also inspect the development and manufacturing sites indicated by the applicant and the related documents.

The hierarchy of standards therefore rewards preparation. Manufacturers holding conformity evidence against Chinese mandatory national standards can assemble the quality-standards section of the dossier from existing test reports and certificates, while manufacturers relying on overseas standards must first confirm that the issuing authority or organisation is recognised by ISAF, and manufacturers with no applicable published standard at all must argue their own standard into acceptance before the dossier is filed. In every case the dossier must show not only the standard but the link between the standard and the four requirements of Article 12, because the review examines the requirements as a set rather than item by item in isolation.

2. Legal basis

The four requirements, the hierarchy of quality standards and the inspection power rest on the following provisions.

3. Expert insights

Insight 1: Placing the mandatory national standards of the Chinese mainland in first position is a clear signal. Article 12(2)(1) lists the mandatory national standards of the People’s Republic of China for medical devices as the first-order basis, alongside standards of other countries and regions recognised by ISAF. Mainland manufacturers enjoy a natural advantage here — existing evidence of conformity with GB standards can directly serve as the quality standards evidence for Macao registration. This positioning also lowers the evidence burden for mainland products that already carry GB conformity documentation.

Insight 2: The fallback provision where standards are lacking leaves room for discretion. Article 12(2)(2) allows the submission of other standards submitted by the applicant and recognised by ISAF. The operational key to this provision is obtaining recognition in advance — enterprise standards, industry standards or association standards should be confirmed as acceptable through pre-procedure consultation before submission, rather than being challenged by a request for supplementation after the dossier has been filed. The pre-procedure consultation record then becomes part of the archived justification for the chosen standard.

Insight 3: The four requirements are cumulative and concurrent. Article 12(1) is worded as must simultaneously comply. This means that conformity with the quality standards cannot compensate for non-conforming instructions for use; a deficiency in any one of the four is a deficiency in the application as a whole. Article 16 of the implementing regulation expressly states that failure to meet the requirements of Article 12 is one of the statutory grounds for refusing registration.

Insight 4: The inspection power extends to development sites. Article 12(3) provides that ISAF may inspect the development and manufacturing sites indicated by the applicant and the related documents. Article 14 of the implementing regulation further distinguishes inspections of development sites from inspections of manufacturing sites, with the former decided by the degree of innovation of the device and the past inspection record of the research institution. Sites and documents indicated by the applicant should therefore be internally consistent with the dossier before submission. This is a regulatory system capable of on-site verification.

4. Practical recommendations

• Prepare the standards list in three tiers: mandatory national standards first, then overseas standards recognised by ISAF, then standards set by the applicant (which require prior recognition).
• Map the standards to the four requirements in the dossier: explain item by item how each adopted standard supports effectiveness, safety and quality control.
• Confirm applicant-set standards through pre-procedure consultation: avoid supplementation after submission because a standard is not recognised; a supplementation request suspends the running of the approval period.
• Prepare the development site for inspection in parallel: research records and data integrity documentation should be retrievable on site.

5. Verification checklist

• □ Applicable mandatory national standards of China for medical devices confirmed and conformity evidence prepared
• □ Where no national standard applies, substitute standards recognised by ISAF confirmed
• □ Where applicant-set standards are used, recognition obtained through pre-procedure consultation
• □ Dossier maps the standards to the four requirements of Article 12
• □ Inspection preparation for development and manufacturing sites completed
• □ Confirmed that the standards applied are current and effective versions

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