3 new guidelines have been released by CFDA from March 22rd to March 24th. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review phase or new submissions. Find out how these guidelines impact your devices in China, please contact us at firstname.lastname@example.org.
1. On March 22nd, CFDA issued a technical review guideline on anastomat.
It is class III with class code 6822. (Different products may have different classification)
This guideline applies to anastomat for endoscopic use, with or without cutting function. This product is mainly used for resection and closure of tissue/organs and reconstruction of digestive tract.
2. On March 22nd, CFDA issued a technical review guideline on dental fiber post.
It is class III with class code 6863.
This guideline applies to dental fiber post product for residual root and crown restoration, including prefabricated fiber post, semi prefabricated fiber post and CAD/CAM integrated fiber post core products. Customized CAD/CAM integrated fiber post core products shall also meet the requirements of relevant regulations of customized medical devices.
3. On March 22th, CFDA issued a technical review guideline on polyurethane foam dressing.
It is class III with class code 6864.
Polyurethane foam dressing is a kind of wound dressing, which is mainly made of polyurethane foam, with porous structure, and can be provided with or without backing wound dressing. It has good absorption capacity of wound exudate. Polyurethane foam dressing can provide a protective barrier for the wound and keep the moist healing environment.
This guideline applies to flake or strip polyurethane foam dressing that conformed to the definition of medical device.