Filing versus Registration: Two Access Pathways in Macao, China

1. Key takeaways

The dividing line between the two pathways is risk: Class I and Class IIa devices take the filing route (Article 24), while Class IIb and Class III devices take the registration route (Article 17). The procedural difference is decisive. Registration comprises four stages — pre-procedure consultation, review, inspection and decision — with a decision period of 70 working days for Class IIb and 100 working days for Class III. Filing has only three stages — pre-procedure consultation, formal review and notification — with the formal review completed within 5 working days and the result notified on the working day immediately following completion. Registration produces a certificate of registration valid for five years; filing produces a filing notice with no validity period.

The practical consequence is that the two tracks must be planned with different lead times and different documentation strategies. Registration dossiers are built around the full technical evidence set and the longer decision periods, while filing dossiers are lean but leave the filer with continuing obligations, including the duty to notify changes and the exposure to cancellation. Choosing between them is not a matter of preference: the class of the device fixes the route, and the route then fixes the evidence, the entity and the timeline; a misjudged class therefore compounds into every downstream step.

2. Legal basis

The two pathways, their stages and their time limits are anchored in the following provisions of the law, the implementing regulation and the fee schedule.

3. Expert insights

Insight 1: Filing is not a simplified version of registration; it is a formal review system. Article 23 of the implementing regulation makes clear that ISAF performs only a formal review of a filing — checking whether the documentation is complete and whether the applicant has the proper standing. This differs fundamentally from the substantive review applied to registration (Article 13(4)). Filing does not mean the technical content will never be pursued: Article 26 provides that a filing may be cancelled, Article 28 governs changes to a filing, and the filer obligations (Article 16) apply in full.

Insight 2: The documentation for filing is drastically reduced. Registration requires 15 items of documentation (Article 10(2) of the implementing regulation), whereas filing requires only four categories (Article 21(2)), and the risk analysis documentation is required only if available. Clinical evaluation documentation, non-clinical evaluation documentation and summary test reports are not on the mandatory filing list.

Insight 3: The filer is not a role the applicant can freely choose. Article 24 works together with Article 11(2): the filing of a Class I or Class IIa device must be submitted by the foreign trade operator where the device is imported. This contrasts with registration, which requires the holder of a trading licence — the threshold for the applicant entity is in fact lower on the low-risk pathway.

Insight 4: The absence of a validity period for filings cuts both ways. There is no renewal burden, but there is also no opportunity for periodic re-examination. Once the labelling, the quality management system or the overseas marketing status of the product changes, a change notification must be submitted proactively under Article 28; otherwise the cancellation ground in Article 26 may be triggered.

4. Practical recommendations

• Choose the pathway by class; do not downgrade to save effort: classifying a Class IIb device as Class IIa in order to file is a classification error, and the consequences once discovered far exceed the time saved.
• Keep a documentation ledger even for filings: although there is no renewal, the obligation to notify changes continues throughout.
• Use pre-procedure consultation for filings too: Article 22 of the implementing regulation provides a pre-procedure consultation stage for filing as well, which can be used to confirm entity qualification and the scope of documentation.
• Secure the foreign trade operator first for imported low-risk devices: without a qualified foreign trade operator, no filing can be submitted.

5. Verification checklist

• □ Pathway (filing/registration) confirmed under Articles 17 and 24
• □ Documentation prepared under Article 10 or Article 21 of the implementing regulation
• □ For imports, applicant entity qualification confirmed (foreign trade operator/trading licence holder)
• □ Formal review of filing (5 working days) and decision period of registration (70/100 working days) understood
• □ Internal procedure for filing change notifications established
• □ Confirmed that a filing has no validity period but carries continuing obligations

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