EVERBIZ | Original compilation. Please credit the source when republishing.
On 28 October 2026, China’s National Medical Products Administration (NMPA) published on its website the Notice on Issuing Four Inspection Guidelines, Including the Inspection Guideline for Sterile Medical Devices under the Good Manufacturing Practice for Medical Devices (NMPA Doc. [2026] No. 16).
The new rules take effect in just days. From 1 November, regulators will assess the results of manufacturing licence inspections and post-market supervisory inspections for four product categories (sterile devices, implantable devices, in vitro diagnostic (IVD) reagents and custom-made dentures) against the newly revised inspection guidelines. The four previous “on-site inspection guidelines” from 2015 and 2016 are repealed on the same day.
1. Timeline of China’s New Medical Device GMP
| Date type | Date | Notes |
|---|---|---|
| Signing date | 23 October 2026 | Date on the Notice |
| Publication date | 28 October 2026 | Made public on the NMPA website |
| Effective date | 1 November 2026 | The 4 new inspection guidelines take effect and the 4 old guidelines are repealed on the same day, aligned with the effective date of the revised GMP |
| Deadline | None set in the Notice | The Notice sets no transition period and no filing deadline for companies. The old guidelines last apply on 31 October 2026 |
Note: Some provincial medical products administrations have set their own self-inspection and corrective-action milestones in their implementation plans for the new GMP (for example, Guangdong Province required companies to complete self-inspection and corrective actions and upload a report by the end of October 2026). These timelines come from local documents; please follow the notice issued by your provincial administration.
Figure: Timeline of documents related to China’s new medical device GMP (compiled by EVERBIZ)
2. Which 4 Guidelines Were Issued, and Which 4 Do They Replace?
| New guideline (effective 1 Nov 2026) | Old document repealed the same day | Old document no. |
|---|---|---|
| Inspection Guideline for Sterile Medical Devices | On-site Inspection Guideline for Sterile Medical Devices | CFDA Doc. [2015] No. 218 |
| Inspection Guideline for Implantable Medical Devices | On-site Inspection Guideline for Implantable Medical Devices | CFDA Doc. [2015] No. 218 |
| Inspection Guideline for In Vitro Diagnostic Reagents | On-site Inspection Guideline for In Vitro Diagnostic Reagents | CFDA Doc. [2015] No. 218 |
| Inspection Guideline for Custom-made Dentures | On-site Inspection Guideline for Custom-made Dentures | CFDA Doc. [2016] No. 165 |
The new documents drop the word “on-site”, in line with the general Inspection Guideline issued in September. Their scope is no longer limited to on-site inspections: they now cover manufacturing licence inspections and all types of post-market supervisory inspections.
3. Where This Notice Fits in the New GMP Framework
The framework can be understood in three layers:
- Layer 1: The revised Good Manufacturing Practice for Medical Devices (NMPA Announcement No. 107 of 2025), published on 4 November 2025 and effective 1 November 2026, replacing the 2014 GMP on the same day.
- Layer 2: The general Inspection Guideline (NMPA Doc. [2026] No. 14), signed on 14 September 2026. It contains 200 inspection items: 39 critical, 88 major and 73 general.
- Layer 3: Appendix-specific inspection guidelines, namely the four issued under this Doc. No. 16, covering sterile, implantable, IVD and custom-made denture products.
Please also note: from 1 November, these four product categories and standalone software products must still comply with both the revised GMP and the current GMP appendices. This Notice does not cover an inspection guideline for standalone software; companies concerned should watch for future publications.
4. What This Means for Companies
- The basis for inspection findings has changed. From 1 November, licence inspections and post-market supervisory inspections for the four product categories will be assessed against the corresponding new guidelines.
- Pending licence applications are affected too. The notice on the general guideline states that licence applications for manufacturing, changes or renewals accepted before 1 November but not yet inspected on site will be inspected against the revised GMP from 1 November. Read together with this Notice, such applications for the four product categories should be assessed against the new guidelines.
- Nonconformities may be “escalated”. Under the general guideline, multiple interrelated nonconformities that could lead to systemic risk are treated as a critical nonconformity in the “Quality Assurance” chapter, and a nonconformity repeated from the previous two inspections may be raised by one risk level as appropriate.
- Contract manufacturers are in scope. The general guideline applies to registrants, filers and contract manufacturers, so every party in the contract manufacturing chain needs to prepare against the new criteria.
5. Priority Actions Before the Deadline
- Download the full text of the 4 annexes from the NMPA website and confirm which guideline(s) apply to your products;
- Run a clause-by-clause gap assessment against the new guidelines, starting with critical items, then major items;
- Check whether findings from previous inspections have truly been closed, as repeated findings may be escalated;
- Confirm that your own and your contract manufacturers’ quality system documents and record templates have been updated to the revised GMP clauses;
- Follow your provincial administration’s implementation plan and inspection schedule; local deadlines are set by the provincial notice.
How EVERBIZ Can Help
EVERBIZ has long supported medical device companies with regulatory registration and quality management system services in China and international markets. For China’s new medical device GMP, we offer:
- Gap assessment between the old and new inspection guidelines, with a corrective action plan;
- Quality management system documentation upgrades (including specific requirements for sterile, implantable, IVD and custom-made denture products);
- Mock inspections and inspection-readiness coaching.
Contact EVERBIZ for a one-to-one consultation.
This article is a compilation of regulatory information and does not constitute legal advice. The original texts published by the NMPA and your provincial medical products administration prevail.
EVERBIZ · Original compilation. Please credit the source when republishing.