Medical Device Industry Standards to be Formulated and Revised in 2021

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  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.