Pre-assessment for Medical Device Technical Requirements


The technical requirements (as well named "product standards") that state the name, model, performance index and inspection methods of the product shall be submitted in the application for product testing. The medical device inspection institute shall accord following aspects in the pre-assessment of product standards:
  • The integrity and applicability of the performance index in product standards; check the operability and repeatability of the inspection methods, and make sure it can match the inspection requirement.
  • All the national standards and industrial standards used in the inspection must be integrated, applicable and appropriate.
  • The testing content that refers to <Chinese Pharmacopoeia> must be integrated, applicable and appropriate.
The inspection institute shall record the existing issues in pre-assessment to the <The Work Dictates for Pre-assessment of Medical Device Product Standards> and give the feedback to the applicant.
 
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