CFDA policies, regulation updates, QA/recall/AE, and new approvals in medical device and IVD for the week of Jan 22-29, 2018:
1. Policy:
CFDA announced Comprehensive Regulatory Plan for Medical Devices (2018-2020). Development plans for active device, passive device and IVD are addressed.
2. Regulation updates:
CFDA issued 9 industry standard documents, including:
- Anesthesia: industry standard of oxygen humidifier
- Dental: industry standard of hose assembles for dental pneumatics
- Dental: industry standard of root canal preparation for dental use
- Dental: industry standard of rotary polishing device for dental use
- Diagnostics: industry standard of technical characteristics of c-arm x-ray
- Hematology: industry standard of continuous hemodialysis machine
- Orthopedics: industry standard of ultrasonic bone tissue surgery equipment
- Sterilization: industry standard of products and processes of moist heat
- Urology: industry standard of camera system for endoscope
3. QA/Recall/AE:
CFDA issued recall alerts for 59 devices. There are three imported devices:
- Hologic: automatic nucleic acid detection system
- Thermo Fisher: freezing microtome
- Siemens: carbohydrate antigen assay kit
4. New Approvals:
CFDA issued the list of medical devices approved in December 2017, including 22 imported class III and 49 imported class II devices.