Common Technical Issues of Active Medical Device 2

Q: What are the requirements for adding models or accessories in the Change of Permission Items?

A: The contents contained in one registration certificate shall comply with the requirements of "Guidance of registrtaion units division for medical device". Whether it is able to add models or accessories into the registration certificate of registered products depends on the difference between the new model and the original model, as well as the relevance between the new accessories and the original products. If the newly added models or accessories and registered products can be divided into the same registration unit according to the guidance, they can be added via the Change of Permission Items.

Q: If Change of Permission Items indicates adding of models, meanwhile new standars are involved, does the original model need to be implemented with the new standard requirements?

A: For instance, the registered models are A and B, and the new models are C and D. Then, for the new models, they shall be implemented with the requirements of the new standard, and the testing report and/or verification/validation data shall be provided.

If the originial models A and B are not changed, then no relevant information is needed and new standard is not added into the Product Technical Requirements. Administrative counterparts shall ensure that A and B can also meet the requirements of the new standard from the date of implementation of the new standard.

If new standard is added into the Product Technical Requirements, testing reports and/or verification/validation data shall be submitted to certify A and B could meet the modified Product Technical Requirements.

Q: Active medical devices contain two different types of product modules. How to determine the product category and classification code?

A: There are many cases of combination products in active medical devices. One product contains two independent functional modules, and each module belongs to a different classification category and code. In this case, the classification level should be managed according to the higher one of the two categories.

For the classification codes, if there is already clearly classified announcement, it shall prevail. If not, administrative counterparts may justify which module of the product is the major one and use the category and code of this module. If manufacture cannot justify, then either one can be used when submitting and no separate classification request is not needed.

For instance of the Integrated Surgical Equipment of Ultrasound and High Frequency, the category code of Ultrasound Surgical Equipment is 01-01-01 and the High Frequency Surgical Equipment is 01-03-01, both of which are class III. If the main function is the ultrasound surgical, then the application category code should be 01-01-01.