Norescience provides full service of medical device registration and inspection (document collation, technical review, CER writing, clinical trial plan, registration approval, import registration and other solutions) to assist your company's products enter the Chinese market.
The relevant regulations are as follows:
Medical Equipment Supervision Regulations 2017
Medical device registration management method (NO 4) CN
Medical machine manual and label management regulations
"Announcement on Announcement of Requirements for Registration Information and Registration Document Format for Medical Device Registration" (No. 43 of 2014)