NMPA (CFDA) Publishes 27 Industry Standards in One Day: Time to Update Your Design Control

NMPA (CFDA) announced revisions of 27 medical device technical standards on June 6, 2019, involving multiple devices including Co-60 Teletherapy Unit, Infusion Sets with Precision Filters for Single Use and Automatic luminescence Immunoanalyzer, etc. If these standards are applicable to your device, please check your product’s design file and your NMPA (CFDA) submitted Product Technical Standards (PTR) in your new or existing relevant China medical devices. “

27 Medical Device Standards Revisions

1. YY 0096-2019 Co-60 Teletherapy Unit (updated from YY 0096-2009, effective since 12/01/2020)
2. YY 0286.1-2019 Special Infusion Sets-Part 1: Infusion Sets with Precision Filters for Single Use (updated from YY 0286.1-2007, effective since 12/01/2020)
3. YY 0585.2-2019 Fluid lines for Use with Pressure Infusion Equipment and Accessories for Single Use-Part 2: Accessories (updated from YY 0585.2-2005, effective since 12/01/2020)
4. YY 1650-2019 Performance and Test Method of X-ray Image-Guided Radiotherapy Equipment (new standard, effective since 12/01/2020)
5. YY/T 0681.16-2019 Sterile Medical Devices – Test Methods for Packaging – Part 16: Climate Strain Capacity Test for Packaging System (new standard, effective since 6/01/2020)
6. YY/T 1645-2019 Human Parvovirus B19 IgG Antibody Detection Kit (new standard, effective since 6/01/2020)
7. YY/T 1648-2019 Correlation Method of Bubble Point Pressure and Bacterial Interception Ability of Filter for Infusion Device (new standard, effective since 6/01/2020)
8. YY/T 1649.1-2019 Interaction Test between Medical Devices and Platelets – Part 1: In Vitro Platelet Counting Method (new standard, effective since 6/01/2020)
9. YY/T 1651.1-2019 Hemolysis Tests on Medical Devices – Part 1: Material Mediate Hemolysis Tests (new standard, effective since 6/01/2020)
10. YY/T 1652-2019 General Technical Requirements for IVD Control (new standard, effective since 6/01/2020)
11. YY/T 1654-2019 Tissue Engineered Medical Products-Part 8: Alginate (updated from YY/T 0606.8-2008, effective since 6/01/2020)
12. YY/T 1655-2019 Fretting Corrosion Test Method of Osteosynthesis Implant Locking Plate and Screw (new standard, effective since 6/01/2020)
13. YY 0174-2019 Scalpel Blade (updated from YY 0174-2005, effective since 6/01/2020)
14. YY 0465-2019 Disposable Membrane Plasmaseparator (updated from YY 0465-2009 , effective since 6/01/2020)
15. YY 0585.1-2019 Fluid lines for Use with Pressure Infusion Equipment and Accessories for Single Use -Part 1: Fluid lines (updated from YY 0585.1-2005, effective since 12/01/2020)
16. YY/T 0324-2019 Infrared Examining Equipment for Mammary Gland (updated from YY 0324-2008, effective since 6/01/2020)
17. YY/T 0339-2019 Suction Catheter for Use in the Respiratory Tract (updated from YY 0339-2009, effective since 6/01/2020)
18. YY/T 0448-2019 Trasonic Doppler Foetal Heartbeat Detector (updated from YY 0448-2009, effective since 6/01/2020)
19. YY/T 0573.3-2019 Sterile Hypodermic Syringes for Single Use (updated from YY 0573.3-2005, effective since 6/01/2020)
20. YY/T 0870.2-2019 Test for Genotoxicity of Medical Devices-Part 2: In Vitro Mammalian Chromosome Aberration Test (updated from YY/T 0870.2-2013, effective since 6/01/2020)
21. YY/T 1155-2019 Automatic luminescence Immunoanalyzer (updated from YY/T 1155-2009, effective since 6/01/2020)
22. YY/T 1213-2019 Follicle Stimulating Hormone Quantitative labelling Immunoassay Kit (updated from YY/T 1213-2013, effective since 6/01/2020)
23. YY/T 1626-2019 Electric Circular Motion Training Equipment for Upper and Lower Extremities (new standard, effective since 6/01/2020)
24. YY/T 1658-2019 Determination Method of Cyclohexanone Dissolution from Transfusion Device (new standard, effective since 6/01/2020)
25. YY/T 1662-2019 Control for Biochemical Analyzer (new standard, effective since 6/01/2020)
26. YY/T 1663-2019 Progesterone Assay Kit (new standard, effective since 6/01/2020)
27. YY/T 1628-2019 PVC Granules for Medical Infusion and Blood Transfusion Device (new standard, effective since 9/01/2019)

ChinaMed Device provides copies of the above standards. Please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

NMPA (CFDA) planned to update 300 technical standards from 2018 to 2020. These technical standards impact your products whether renewal or new registration. All products have to be brought to the latest NMPA (CFDA) technical standards! ChinaMed Device has a team of technical engineers who can assist you to understand the technical standards and their impacts on your products: 

• Assessing relevancy of the new standards to your products
• Gap analysis between your product and current NMPA (CFDA) standards
• Mock testing for your product compliance
• Writing and updating your Product Technical Requirement (PTR).
• Local type testing on-site support at NMPA (CFDA) testing centers
• Software compliance to NMPA (CFDA) framework, cybersecurity and wireless access
• Assisting in design input
• Customized NMPA (CFDA) regulations and standards update    

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ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.