Notice For Basic Principles Of Medical Device Safety And Performance Compliance Technical Guide Released
2022-08-01
On July 13, 2022, CMDE of NMPA issued a notice of the Compliance Technical Guideline of Essential Principles of Medical Device Safety and Performance (hereinafter referred to as the “Essential Principles”).
The Essential Principles is the basic requirements for the safety and effectiveness of medical devices based on risk. The applicant for registration should consciously fulfill the main responsibility to integrate the requirements of the Essential Principles into the development and manufacturing process of medical devices, under the control of the quality management system to form the corresponding evidence of compliance, submitted as proof of product safety and effectiveness during registration.
BradyKnows can help guide applicants to register filing in a scientific and reasonable manner. If you have any questions on medical device registration, please contact info@bradyknowsmedical.com.
