8 kinds of medical device products are no longer mandatory certification

Recently, AQSIQ, the State Food and Drug Administration, and the National Certification and Accreditation Regulatory Commission jointly announced that they will no longer impose mandatory product certification management on eight types of medical device products and include medical device registration management.

The eight types of medical devices include medical X-ray diagnostic equipment, hemodialysis devices, hollow fiber dialyzers, extracorporeal blood circuits for blood purification devices, artificial heart-lung machines, electrocardiograph devices, implantable pacemakers, and rubber condoms.

Our country implements a product registration system for medical devices, and companies can only produce medical devices after obtaining a medical device product registration certificate. At the same time, the state implements compulsory product certification management for some products. Products that are listed in the compulsory certification product list must pass the certification of the national designated agency and be marked with the certification mark before they can be shipped, sold, imported, or used in other business activities. . The compulsory certification catalogue is dynamically adjusted by relevant state departments according to relevant laws and regulations, production technology levels, and product safety risks.