On 18 March 2021, China’s National Medical Products Administration (NMPA) has published a notice of the State Food and Drug Administration on the study, publicity, and implementation of the “Regulations on the Supervision and Administration of Medical Devices” taking effect starting from 1 June 2021. In the notice, to have a better understanding of the “Regulations” through study, publicity and implementation, the relevant matters follow:
Fully understanding the necessity of revising the “Regulations” and the important significance of the study, publicity, and implementation.
In-depth understanding and learning, and accurate grasp of the basic content of legislation.
Speed up the formulation and revision of supporting regulations and documents to ensure effective implementation.
Innovative methods, and actively carry out publicity and training.
Consolidate the supervision foundation, strengthen the supervision system and supervision capacity building.
Comparing the previous draft for the “Regulations” published in 2018, the notable changes are:
In article 14 – In-country testing may no longer be strictly required for all Class II and Class III device registration.
In article 24 – Clinical evaluation exemption criteria approval may be expanded.
In article 15 – The requirement for home-country approval for Innovative Device applications has been eliminated.
In article 46 – New requirements have been introduced pertaining to online sales
In Chapter 7 – Penalties directed at companies in violation of the Regulations have been strengthened.
Sources:
National Drug Administration Law (2021) No. 19 Regulations on the Supervision and Administration of Medical Devices Amendments to the Regulations on the Supervision and Administration of Medical Devices
Contact us at info@arqon.com for more info