Innovative medical device products approved has reached 120

According to information published by the National Medical Products Administration, September 1, 2021, the total number of innovative medical device products approved for marketing in China has reached 120.

Favorable policies continue to be released, and innovation drives development planning and construction. In the future, supporting the clinical and use of innovative medical devices, improving independent innovative medical capabilities, and promoting the development of the medical device industry will be the main promotion of the development of medical devices. For urgent clinical needs and vacancies in the medical market, the government has opened a fast-track review channel.

For example, the Approval Center reviewed Shockwave Medical’s (U.S.) coronary intravascular shock wave catheter registration application and determined that the product meets the priority approval situation and plans to give it priority approval. TriReme Medical’s (U.S.) paclitaxel drug-coated peripheral balloon catheter and Boston Scientific Corporation’s (U.S.) vascular plaque atherectomy system have entered special review procedures.

It should be noted that entering the innovation review process does not mean that the product has been determined to be safe and effective for registration. Applicants still need to carry out research and development and submit registration applications in accordance with relevant requirements. The drug regulatory authority and related technical institutions will follow the early intervention, The principle of dedicated personnel responsibility and scientific review is to conduct review and approval under the premise that the standards and procedures are not reduced.

(Source: China Net Medical Channel)