On March 2, 2022, the National Medical Products Administration issued their Announcement on Filing of Class I Medical Devices (hereinafter referred to as “the Announcement”) to call for public comments. The comment soliciting period will last from the issuing date to March 31, 2022. The Announcement is a revision of the original version (currently effective) issued in 2014. Once this new revision is implemented, it will replace the current version immediately.
The Announcement is composed of 9 articles that specify
relevant aspects of filing work for class I medical devices (including class I in-vitro
diagnostic reagents) including: i) definition of filing medical devices; ii) respective
departments; iii) product classification; iv) material requirements; v) procedure
and timelines: vi) filing changes.
The document also contains several annexes that offer
further detail for stakeholders looking into the implementation process. The
annexes are:
· Requirement and explanation for the filing of class I medical devices
· Filing form for class I medical devices
· Information forms for class I medical devices and class I in-vitro diagnostic reagents
· Operation instructions for the filing of class I medical devices
For MNCs and foreign stakeholders, it is advised to
actively participate in the call-for-comment work and submit feedbacks if there
is any. Meanwhile, the revision of the Announcement is in accordance with regulations
from the same sector that was revised/issued in 2021. Such stakeholders also
are suggested to pay attention to consistencies between the relevant documents
listed below:
Regulation on the Supervision and Administration of Medical Devices (2021
Revision)
Issued by the State Council under Order No. 739 of the State Council of the People's Republic of China on February 9, 2021. It came into effect on June 1, 2021.
Measures for the Administration of Registration and Filing of Medical Devices
Issued by the State Administration for Market Regulation (SAMR) under Order No. 47 of SAMR on August 26, 2021. The regulation became effective on October 1, 2021.
Measures for the Administration of Registration and Filing of In-Vitro Diagnostic Reagents
Issued by SAMR under Order No. 48 on August 26, 2021. This document also took effect on October 1, 2021.
If you need more information on the topic, please contact: