Registration Approval Timelines of 70 and 100 Working Days

1. Key takeaways

Article 17 of the Implementing Rules is the core provision on scheduling: the decision on a registration application should be made within a period counted from the date on which the application and the information required for approval are complete — 70 working days for Class IIb devices and 100 working days for Class III devices; owing to the degree of complexity or other reasonable grounds, the Director of ISAF may extend the period by up to 45 working days as an exception, and shall notify the applicant before the expiry of the original period. The key mechanism is the suspension of the count: when ISAF requests the submission of further information or notifies the correction of deficiencies, the period is suspended from the date of the notification until the date on which the submission or correction is completed.

• The 70 and 100 working-day periods run from the date the dossier is complete, not from the date of submission.
• The suspension mechanism has no upper limit and is the main source of schedule overruns.
• Any extension must be notified before the original period expires, giving the applicant a predictable checkpoint.
• Changes to registration information requiring prior approval carry a separate period of up to 100 working days, extendable by 45 working days.
• Patent-protected devices under Article 15 sit outside the general approval period and must be scheduled separately.

2. Legal basis

The approval periods, extensions and suspension mechanism for registration are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: the 70 and 100 working days run from the point at which the dossier is complete, not from the point of submission. The starting point under Article 17(1) is the day on which the application and the information required for approval are complete. Before that point, there is still the 20-working-day formal review under Article 13. Adding the two segments together, the best-case schedule is approximately 90 working days for Class IIb and approximately 120 working days for Class III (a practical estimate, excluding correction and inspection time).

Insight 2: the suspension clause is the main source of schedule overruns. Article 17(3) lists two suspension scenarios: (1) a request under Article 10(5) for the submission of further information; and (2) a notice under Article 13(5) to correct deficiencies. The suspension period has no upper limit — which means that in theory the approval can remain pending indefinitely. The only way to control the actual cycle is to complete the dossier in one pass. Every request for further information or notice of correction restarts the clock only after the applicant has responded, so the elapsed time between the two dates is entirely within the applicant’s own control.

Insight 3: an extension must be notified before the original period expires. Article 17(2) requires the Director of ISAF, when extending, to notify the applicant before the expiry of the original period. This gives the applicant a predictable checkpoint: if no extension notice has been received before the 70th working day (for Class IIb), the approval period has already expired.

Insight 4: the decision period for changes to registration information is longer. Article 19(5) provides that for changes to registration information requiring prior approval, ISAF shall make a decision within up to 100 working days from the date on which the information is complete, and the period may likewise be extended by 45 working days. The time cost of a major change can approach that of a full registration.

Insight 5: Article 15 (patent-protected medical devices) is excluded from the application of Article 17(1). For devices involving patents, the general approval period of Article 17(1) does not apply, and scheduling must be assessed separately.

4. Practical recommendations

• Build a dossier-complete-date ledger: treat the date on which ISAF confirms that the dossier is complete as the scheduling start point, not the submission date.
• Treat deficiency corrections as project risk: every correction suspends the running of the period, so an internal review should be completed before the first submission.
• Use the 70th and 100th working days as monitoring checkpoints: if no extension notice has been received by the deadline, proactively query ISAF on progress.
• Schedule major changes at 100 working days: do not treat a change as a fast-track process.
• Reserve separate time for patent-related products: the general approval period does not apply in the situations of Article 15.

5. Verification checklist

• □ It has been confirmed whether the product falls under 70 working days (Class IIb) or 100 working days (Class III)
• □ The 20-working-day formal review has been included in the overall schedule
• □ The two suspension scenarios of Article 17(3) have been identified and entered into the risk register
• □ Monitoring and query mechanisms for the 70th and 100th working-day checkpoints have been set up
• □ Major changes have been scheduled at up to 100 working days
• □ The approval period for patent-related products has been assessed separately

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