In cooperation with Swiss-based ISS AG, Qualtech held a webinar on the subject of China’s New Regulation for Supervision and Administration of Medical Devices (RSAMD) on June 30th. The new decree No.739 had recently been issued by the Chinese authorities and has gone into force on June 1st, 2021.
Important updates include, among other things, China NMPA’s newly implemented measures to specifically encourage innovative medical devices. That is, by allowing for simplified and priority review pathways and approval procedures. Besides the former, NMPA further added conditional approval pathways as well as emergency use regulations for selected urgently needed medical devices.
Another novelty stemming from the new RSAMD is that NMPA will also start to accept self-testing reports for products other than Class I Medical Devices under certain conditions. Thus, extending the limitation previously set by the old RSAMD Decree No. 680. Manufacturers may therefore be able to save a significant amount of time and cost for type testing, in case their self-testing report is considered eligible.
During the one-hour webinar, Qualtech further elaborated on the new obligations for product registrants under the new nationwide adopted marketing authorization holder (“MAH”) system in China.
● Registrants are obligated to establish a quality management system suitable for the product and shall further formulate post-market research and risk control plans.
● In addition, registrants shall also launch adverse event monitoring and re-evaluation according to the China regulations.
● Furthermore, product traceability and a recall system shall be established and implemented.
● Generally, it is thereby essential to remember that the MAH/Registrant is now responsible for the safety, quality, and efficacy of the medical device throughout its entire life cycle.
The new RSAMD also brought reforms in the clinical evaluation requirements along with broader exemption from clinical evaluations. Clinical evaluation can now be exempted in case one of the following two criteria are fulfilled:
►(1) A medical device with a clear-cut functioning mechanism, an established design, a matured manufacturing process, the on-market substantial equivalent medical device has no record for serious adverse events and has been marketed and clinically applied for multiple years, while at the same time not having changed its conventional purpose.
►(2) The safety and effectiveness of the medical device can be proven by non-clinical evaluation.
A last key aspect is represented by the strongly enhanced supervision system, which is being further supported by a sharp increase in penalties for committed violations.
Shall you have any questions regarding the new RSAMD or in case you are interested in registering your products on the Chinese market, please feel free to contact us at your earliest convenience: irene@qualtechs.com
References:
China’s New Regulation for Supervision and Administration of Medical Devices (RSAMD) – For the moment only available in the original Chinese language version