The medical device technical team of CIRS Group was invited to attend the event, and jointly held a special seminar on FDA & CE MDR Certification and NMPA Clinical Evaluation with the organizer. Empowering Chinese, Korean and global medical device enterprises to comply with regulations and expand overseas with professional regulatory services, CIRS Group has gained high attention and wide recognition from the industry.
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.
