The NMPA published 14 guidelines on July 6, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.
For English version of any guidelines below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
Full List of Guidelines July 2023
The guidelines impact the devices as follows:
- blood melting device
- respiratory humidifier
- intestinal hydrotherapy machine
- molecular sieve oxygen generator
- bladder ultrasound scanner
- single-use peritoneal dialysis catheters
- respiratory filters
- oropharyngeal/nasopharyngeal airway
- liquid dressings
- gel dressings
- β-hydroxybutyric acid detection reagent
- methotrexate detection reagent
- anti-cyclic citrullinated peptide antibody detection reagent
- Gram-positive bacteria identification reagent
Huge Impact
Whether you are renewing or submitting new registration, your medical devices need to meet these new guidelines. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new guidelines.
As a result, your originally approved products will still need to go through local type testing to show that you are current with the new guidelines. China Med Device, LLC在 NMPA 测试中心拥有测试工程师，可帮助您评估和加快您的型式测试需求，缩短您的更新或新批准时间。