China NMPA published 14 final guidelines on July 6, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions:
- blood thawing 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
69 guidelines have been released. All these 14 guidelines released on July 6 are final for review.
Huge Impact
If there is a product change before the renewal, the manufacturer needs to apply modification on permission items to NMPA first.
If the product has not changed and the referred mandatory standards such as GB or YY standards are upgraded, the manufacturer needs to do the local type testing first before submitting the modification. Once the manufacturer obtains the approval in modification on permission items by NMPA, and then you can do the renewal.
If it is the first registration of your product, the manufacturer needs to comply with the latest guidelines.
If your products are impacted by the guidelines update or have any questions, please email me.
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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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