New Medical Device Industry Standards and Amendments
On February 25 and 26, 2020, NMPA announced that 13 new medical device industry standards have been approved as well as a medical device industry standard amendment. 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 | Effective Date |
| YY 0167-2020 | Non-absorbable surgical suture | 2021-3-1 |
| YY 1116-2020 | Absorbable surgical suture | 2021-3-1 |
| YY/T 0573.4-2020 | Sterile hypodermic syringes for single use—Part 4: Sterile hypodermic syringes for single use | 2021-3-1 |
| YY/T 0823-2020 | The fluoride compounds for dental carious prevention materials | 2021-3-1 |
| YY/T 1693-2020 | Dental maxillary sinus membrane elevator | 2021-9-1 |
| YY/T 1710-2020 | Disposable abdominal trocars | 2021-3-1 |
| YY/T 1720-2020 | Standard test method of determining the forces for disassembly of modular acetabular devices | 2021-3-1 |
| YY/T 0292.1-2020 | Protective devices against diagnostic medical X-radiation—Part 1: Determination of attenuation properties of materials | 2021-3-1 |
| YY/T 0292.2-2020 | Protective devices against diagnostic medical X-radiation—Part 2: Protective glass plates | 2021-3-1 |
| YY 0450.1-2020 | Accessory devices for sterile single-sue intravascular catheters—Part 1: Introducer | 2021-8-1 |
| YY/T 0621.2-2020 | Dentistry—Compatibility testing—Part 2: Ceramic -ceramic systems | 2021-3-1 |
| YY/T 1656-2020 | Diagnostic kit for morphine (colloidal gold) | 2021-3-1 |
| YY/T 1671-2020 | Ultrasound biopsy guide | 2021-3-1 |
| Amendment Number | Amendment Name | Effective Date |
| YY/T 0935-2014 | Particular specifications for CT injector | 2020-2-26 |
Link:
http://www.nmpa.gov.cn/WS04/CL2138/375229.html
http://www.nmpa.gov.cn/WS04/CL2138/375228.html
