The Guideline on Preparation of Medical Device Technical Requirements


The product technical requirements, we call it product standards also, which mainly involves the performance index and corresponding test method. To compile the product standard, you shall include items as follows:
  1. Name
The name in product standard shall be in Chinese and be consistent with the name in registration or record keeping procedure.
  1. Model and/or Specification
State the definite model and/or specification in the product standard; for the case that there are several models and/or specifications for one registration product, state clearly the difference among models and/or specifications.
  1. Performance Index
The performance index indicated here is the functionality index, safety index and other index relevant to the safety control, and can be objectively determined. The establishment of the performance index shall refer to the national standard/professional standard and in accordance with the design characteristic, intended use and safety control level of the product, and no lower than the applicable national standard/professional standard of the product.
  1. Test Method
When you establish the test method for the corresponding performance index, you may give priorities to adopt the issued certain test method and guarantee the repeatability and operability of the test method; indicate the preparation method of samples if needed, and the diagram is allowed if it has to. For IVD product, you shall specify the used standard substance, the quantity of tested reagents, test numbers and calculation method in the test method as well.
  1. For Class Ⅲ IVD products, the product standard shall include the raw materials, production technique and semi-manufactured goods as appendixes.
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