NMPA issued four draft clinical guidelines on December 11, 2023. Feedback needs to be submitted by January 2, 2024.
For an English copy of any guideline below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
NMPA Four Draft Clinical Guidelines:
- Clinical Trial Guideline on intracranial thrombectomy stent
- Clinical Trial Guideline on facial injection filler material
- Clinical Evaluation Guideline on extracorporeal membrane oxygenation system
- Clinical Evaluation Guideline on same-variety comparison of spring coil system
The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities.
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines. As a result, approved products still need to go through local type testing to show that they are current with these new requirements.
China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.