On What Conditions Can Surgical Instruments Be Exempted From Biological Tests？
Based on the current level of knowledge, biological tests can be exempted if the following conditions are satisfied: Material chemical composition verification data are provided. The production process does not affect the chemical composition of the material, verification data can be submitted in the form of a material list of raw materials. The materials used in surgical instruments that come into contact with patients (directly or indirectly) are only composed of metals. Metal materials are verified to meet the relevant national, industrial and international standards for metallic materials for surgical implants or materials for surgical instruments, as well as the brand specified in applicable national and industrial standards for specific products. For example, the material brand specified in YY/T 0176 General Technical Conditions for Medical Scissors.
Guideline on Market Access for Medical Device in China
Guideline on Market Access for Medical Device in China is a report drafted by CIRS Group- Medical Device BU to help companies and individuals who would like to sell their medical devices to the People’s Republic of China and get their medical device products registered with NMPA. The guide describes key definitions, main regulations, authorities of the medical devices in China, and also the requirements of the whole life-cycle of medical devices including pre-registration preparatioin, registration process, testing/inspection, clinical evaluation, QMS and post-market management.