On November 24, 2011, the Chinese SFDA announced the Notice for Clinical Trial Waiver Concerning Certain Class II Devices, effective immediately. The notice lists 21 types of Class II devices eligible for waiver of local registration trials. Applicants seeking the waiver must submit comparison data that demonstrate the new product’s similarity with an existing, approved product. The waiver aims to more strictly regulate the registration of Class II devices while allowing expedited approval for select product types.
The product comparison data must include: information on functional mechanisms, product materials, structural composition, primary technical performance indicators, methods of sterilization (if applicable), expected uses, and whether the products are intended for household use. Companies are advised to consult the China SFDA or provincial FDAs when preparing the comparison data.
For the 21 types of Class II devices eligible for waiver, see the list below. For specific SFDA product category codes and examples, see original Notice on the China SFDA website: http://www.sfda.gov.cn/WS01/CL0845/67233.html (Chinese).
- Basic surgical instruments
- Operative orthopedic surgical instruments
- Injection and puncture instruments
- Devices for general examination
- Medical electrical devices
- Medical optical and endoscopic devices
- Medical ultrasonic devices
- Medical and surgical electrodes
- Traditional Chinese medical devices
- Medical X-ray auxiliary parts and equipment
- Devices for clinical lab tests (hematology, etc.)
- Equipment for clinical laboratories
- Equipment for cardiopulmonary bypass and blood circulation
- Equipment for surgical and ER rooms
- Equipment for dentistry and stomatology
- Equipment for ward rooms
- Equipment for sterilization
- Equipment for medical cold therapy / low temperature storage
- Materials for dentistry and stomatology
- Medical dressing and garments
- Medical polymer materials and products (one-time disposable)