The Notification Pathway and Its Five Working-Day Formal Review

1. Key takeaways

Notification is the market pathway for Class I and Class IIa devices, and its procedure has only 3 stages: pre-procedure consultation → formal review → notification. ISAF must complete the formal review within 5 working days from receipt of the application and notify the result on the immediately following working day after completing the formal review. The documentation for notification is substantially simplified compared with registration, requiring only 4 categories of documents (risk analysis information being submitted where available). In import scenarios, notification must be filed by a foreign trade operator — this is the entity threshold of the low-risk pathway.

• The 5-working-day formal review is a statutory maximum, and correction time is excluded from the count.
• Only 4 categories of documents are required, and clinical and testing information is not among them.
• The foreign trade operator is the key to the low-risk import channel.
• Notification has no fixed term of validity, but the rules on changes and cancellation still apply.
• The pre-procedure consultation stage is also available for notification, allowing the entity and the document scope to be confirmed at low cost before filing.

2. Legal basis

The stages, documentation, formal review and notification of the notification procedure are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: the 5 working days are a statutory maximum, not an average duration. Article 23(1) uses the word must, which constitutes a time-limit constraint on ISAF; however, paragraph 2 of the same article provides that where the notification is deficient in its composition, ISAF shall notify the applicant to correct the deficiencies within a specified period — the correction time is not counted within these 5 working days. Companies should earn this speed by completing the dossier in one pass.

Insight 2: the documents for notification number only 4 categories, and they exclude clinical and testing information. Article 21(2) of the Implementing Rules lists: applicant-related documents; the criminal record certificate and the certificate of no debt; risk analysis information where available; and the documents under Article 10(2), items (4), (7), (11), (13) and (15) (declaration of standing, technical requirements, label and instructions-for-use specimens, evidence of marketing overseas, and patent certificate or declaration). Clinical evaluation information and non-clinical evaluation information are not on the notification list.

Insight 3: the foreign trade operator is the key to the low-risk import channel. Article 11(2)(1) of Law No. 12/2025 requires that Class I and Class IIa notifications be filed by a foreign trade operator meeting the requirements. Article 21(3) of the Implementing Rules further provides that where the applicant holds a manufacturing licence or is a foreign trade operator, the documents under items (1) and (2) (applicant information, criminal record certificate and certificate of no debt) need not be submitted — the status itself substitutes for part of the documents.

Insight 4: notification has no fixed term of validity, but the rules on changes and cancellation apply equally. Article 24 issues the notification notice, Article 26 allows cancellation of a notification, and Article 28 governs changes to a notification. The absence of a renewal step means there are no periodic review reminders, and companies must build their own change-trigger mechanisms.

4. Practical recommendations

• Secure the foreign trade operator first: the first step in importing low-risk devices is to identify a qualified foreign trade operator; without one, the notification simply cannot be filed, and no amount of document preparation can substitute for that status.
• Use the pre-procedure consultation to confirm the scope of documents: Article 22 also sets a pre-procedure consultation stage for notification, allowing the entity and the documents to be confirmed at low cost.
• Complete the dossier in one pass: correction time is not counted within the 5 working days, so document quality directly determines the actual speed; the aim should be a first-pass acceptance without any correction round.
• Build a change-trigger list for the notification: changes to the product name, labelling, overseas marketing status or applicant information must be proactively notified as changes, since no periodic review will ever remind the company of them.

5. Verification checklist

• □ It has been confirmed that the product is Class I or Class IIa (notification applies)
• □ For import scenarios, a qualified foreign trade operator has been identified
• □ The 4 categories of documents under Article 21(2) have been assembled
• □ Whether to submit the risk analysis information has been assessed under the where-available principle
• □ The pre-procedure consultation has been completed and the scope of documents confirmed
• □ A notification-trigger mechanism for changes to the notification documents has been established

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