NMPA Issued Notifications on Medical Device Industry Standards and an Amendment
On April 9, 2020, NMPA announced that 12 medical device industry standards and an amendment have been approved. Details about the standards and amendment is listed in the table below for your reference. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines.
| Standard Number | Standard Name | Implementation Date |
| YY 0336-2020 | Sterile vagina dilator for single use | 2021-4-1 |
| YY/T 0286.6-2020 | Special infusion sets. Part 6: Flow rate-setting and adjustable infusion sets for single use | 2021-4-1 |
| YY/T 0681.18-2020 | Test methods for sterile medical device package–Part 18: The vacuum attenuation method is used to nondestructive test for packing leakage | 2021-4-1 |
| YY/T 0771.1-2020 | Medical devices utilizing animal tissues and their derivatives Part 1 : Application of risk management | 2021-4-1 |
| YY/T 0771.2-2020 | Medical devices utilizing animal tissues and their derivatives.Part 2:Controls on sourcing,collection and handling | 2021-4-1 |
| YY/T 1477.5-2020 | Standard test models for primary wound dressing performance evaluation—Part 5: In vitro model for evaluating hemostatic properties | 2021-4-1 |
| YY/T 1667-2020 | Anti-Mycoplasma pneumoniae ELISA (IgG) | 2021-4-1 |
| YY/T 1676-2020 | Ultrasonic endoscope | 2021-10-1 |
| YY/T 1684-2020 | Dentistry – Electronic Apex Locator | 2021-10-1 |
| YY/T 1695-2020 | Medical devices for human assisted reproductive technology – The test method for amino acids in human assisted reproductive medium | 2021-4-1 |
| YY/T 1717-2020 | Nucleic acid extraction kit (magnetic bead method) | 2021-4-1 |
| YY/T 1718-2020 | Medical devices for human assisted reproductive technology – Embryo Transfer Catheter | 2021-4-1 |
| Amendment Number | Amendment Name | Implementation Date |
| YY/T 1617-2018 | PVC calendered film for blood bag | 2020-4-9 |
