On July 7, NMPA issued the notice that a total of 77 industry standards will be formulated and revised in 2021.
The formulation and revision of the industry standards involves:
- Tissue engineering medical devices
- Nano medical devices
- Assisted reproductive medical devices
- Medical devices of medical additive manufacturing technology
- Artificial intelligence medical devices
- Medical clinical laboratory and in vitro diagnostic system
- Medical biological protection products, surgical implants and orthopedic devices (including orthopedic implants and cardiovascular implants)
- Physical therapy equipment
- Medical electronic equipment
- Anesthesia and respiratory equipment
- Medical syringes (needles), family planning equipment
- Medical infusion equipment
- Medical health materials and dressings
…
Special attention need to be paid to if you have relevant products.
As the boom of medical device industry, increasing enterprises are pouring into this filed. To strengthen the surveillance of medical devices, NMPA has made constant efforts to continue to improve its regulations and standards.
Mastering the technical standards can give manufacturers advantage to compete in the market. IMD can provide manufacturers with all kinds of standardized consultation and standardized training services. Please do not hesitate to contact us at info@inspirativemed.com, if you have any question in the gap between your products and NMPA’s standards.
Link: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20210707141730119.html