This guide has been developed to clarify the approval process for "combination products of medical devices and quasi-drugs" by providing submission requirements, review criteria, and examples for products packaged together.
Approval may be applied for as a medical device only when the "primary intended use" of the combination product aligns with that of a medical device. When medical devices and quasi-drugs are co-packaged, their purposes and methods of use must be compatible.
For combination products where medical devices and quasi-drugs are packaged together, the application for medical device approval must include technical documentation as an attachment to the medical device approval application form. If the product includes quasi-drugs, the Medical Device Review Division will conduct a joint review with the Cosmetic Product Review Division. Following the joint review, the Medical Device Review Division will consolidate any supplementary requirements or approvals related to the quasi-drug from the Cosmetic Product Review Division and forward them to the approval department, which will then notify the applicant of the review outcome.
If the combination product consists only of previously approved (certified, notified) items, the application can proceed without a technical document review. In such cases, the medical device application form must include attachments such as the respective approval (certification, notification) certificates for both the medical device and quasi-drug, a GMP compliance certificate, or a self-declaration of quality conformity.
Please refer to the attached document below.
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