We know that some active medical device registered products have the form of optional accessories, so for the second class of passive medical device registered products, can there also be "optional accessories"?If so, which accessories can be "optional"?Let's look at the text together.
Can there be "optional accessories" for Class II passive medical device registered products?
OK. Optional accessories are an enhancement and optimization of product functions on the basis of necessary parts, and do not affect and change the overall function and intended use of the product. In order to achieve different functions, Class II passive devices should be used with different "optional accessories", and "optional" should be indicated after the corresponding components in the structure and composition when applying for medical device registration. When determining the typical products in the medical device registration unit, the most functional, complex and highest-risk products, including "optional accessories", should be considered as the typical products.
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