The number of innovative medical devices approved for market reached a new high in 2022!

The situation of innovative medical devices approved for market in 2017-2021 is shown in the figure below. According to the data in the figure, 54 innovative medical devices were approved for market in 2022, which hit a new high in nearly six years.

In order to encourage medical device innovation and encourage the high-quality development of the industry, the NMPA revised and issued the Special Review Procedure for Innovative Medical Devices in 2018. The Regulations on the Supervision and Administration of Medical Devices, which came into effect on June 1, 2021, also proposed that innovative medical devices should be given priority for review and approval.

In order to speed up the launch of innovative products, the national drug regulatory department has issued relevant operation specifications, improved the review and evaluation workflow, opened the green channel for innovative medical devices, actively solved the problems existing in the key technical nodes of applicants, and given priority to the review and approval without lowering the standards and procedures, so that innovative products can “queue alone and run fast all the way”.

At the same time, innovation service stations have been established in some provinces (autonomous regions and municipalities) to strengthen the guidance for local innovative medical device application.

Financial support

Shanghai and Jiangsu have issued relevant financial support policies for innovative medical devices.

The people’s Government of Jiangsu Province issued a circular on a number of policies and measures to promote the overall improvement of economic operation:

It mentioned that medical device products entering the national and provincial special examination procedures for innovative medical devices, as well as medical device products entering the above procedures, obtaining the registration certificate of medical device for the first time (Category 3) and manufactured in the province, will be given up to 20 million yuan in financial support.

The General Office of the Shanghai Municipal People’s Government printed and distributed the Several Policies and Measures for Shanghai to Accelerate the Construction of a Global Biopharmaceutical R&D Economy and Industrialization Highland:

It refers to the special review procedure for the entry into the national and municipal innovative medical devices. The registration applicant of this city obtains the medical device registration certificate for the first time, and entrusts enterprises in other provinces and cities (including affiliated companies) to produce the medical device products that achieve the output. According to the procedure, the qualified medical devices will be given no more than 30% of the R&D investment and no more than 5 million yuan at most; The cumulative amount of support for each unit per year shall not exceed 12 million yuan.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：CMDRA

Translated & edited by Bradyknows