NMPA published 12 medical devices guidelines on August 12, 2024. They are aimed to facilitate manufacturers with clarity in registration process.
Significance of Device Guidelines
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.
Full List
For English version of any guidelines below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation. We will also give you the email and phone number of contact person that NMPA assigned for the guideline.
The guidelines impact the devices below:
- Hydrogel dressing (Class III)
- Dialysis fluid filter
- Disposable side-hole blunt needle
- Disposable intravenous indwelling needle
- Medical devices using nanomaterials (for safety and efficacy evaluation, particularly biocompatibility and toxicology)
- α-Cyanoacrylate medical adhesive
- Absorbable anti-adhesion products for abdominal and pelvic surgery
- Absorbable surgical sutures
- Absorbable hemostatic products
- Disposable membrane oxygenator (for CPB use)
- Disposable cerebrospinal fluid shunt
- Disposable hemodialysis tubing
