On August 6, CFDA published 17 industry standards, covering sterilization of infusion device, biological testing, and standardization of medical consumables.
1. Test methods for packaging of sterilized medical devices: Breathable packaging material aerosol filtration method microbial barrier test
2. Test methods for packaging of sterilized medical devices: Non-destructive testing of packaging leaks by vacuum attenuation method
3. Intravascular catheters – Disposable sterile catheters: Subcutaneous implantable devices
4. Special requirements for safety of blood, intravenous liquid and lavage warmer
5. Determination of 2-chloroethanol residues in disposable PVC infusion devices
6. Large-aperture connectors for medical fluids and gases: connector for gastrointestinal use
7. Small aperture connectors for medical liquids and gases: axle connector
8. Special infusion sets: Infusion sets for single use
9. Special infusion sets: Scale flow adjustment
10. Determination of strength and curing time of synthetic water-activated polyurethane glass fiber orthopedic bandages
11. Standard Test Model for Evaluation of Performance of Contact Wound Dressings: In vitro model for evaluation of hemostatic properties
12. Disposable medical gloves: resistance to chemical penetration
13. Medical device complement activation test: determination of complement activation products (C3a and SC5b-9)
14. Evaluation for immunogenicity of medical device: determination of spleen lymphocyte subsets in animals by flow cytometry
15. Medical Device Biological Evaluation: medical device neurotoxicity test selection guide
16. Medical device genotoxicity test: In vitro mammalian cell micronucleus test
17. Medical device and platelet interaction test: In vitro platelet activation test
For complete versions of industry standard mentioned above, please email info@ChinaMedDevice.com.
For 2018 Standardization Revision Plan, please email us too.
China Med Device, LLC (https://ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post-market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.