China CMDE recently issued an interpretation of the guidelines for Registration Review of Medical Device Usability Engineering. In this document, China CMDE interpreted the background of the guideline. It is also to follow the medical device regulators in US and CE. Class II/III registration shall follow the guideline, but IVD is excluded. The key points …
According to Announcement No. 30-2022, RF therapy and RF skin therapy devices (Product code #09-07-02) shall be regulated as Class III medical devices. Announcement No. 30-2022 mainly provided new requirements of the classification and regulation of RF devices intended to be used in the aesthetic field. The following aspects represent the current thinking of NMPA. …
This article is focus on how to deal with the renewal of existing registrations, the adoption of new and recommended standards, and the modification of product instructions and labels. 1. Renewal of Existing Registrations: If medical devices applying for registration renewal can’t meet the new mandatory standards, the renewal will not be granted. Existing registrations …
The State Food and Drug Administration issued the “Guidelines for the Registration and Review of Animal Experimental Research on Medical Devices Part I: Decision-Making Principles (2021 Revision)” and “The Second Part of the Guidelines for the Registration Review of Medical Device Animal Experimental Research: Experimental Design and Implementation Quality Assurance” (Notice No. 75 of 2021) …
1. Drafting background The classification of medical devices (including in vitro diagnostic reagents) in my country implements the classification catalog system under the guidance of classification rules. Classification rules and classification catalogs coexist, and the classification catalog takes precedence. Different from the “Medical Device Classification Rules”, the Bureau did not issue the classification rules of …
Interpretation of “Classification Rules for In Vitro Diagnostic Reagents” Read More »
