When developing combination products, the local legal requirements are highly variable.
In the US, the Food and Drug Administration (FDA) has laid out requirements for the development and manufacture of combination products in CFR Part 4. In addition to good manufacturing practices (GMP) requirements for medicinal products (12 CFR 210/211), relevent controls (certain sections of 21 CFR 820) for the product and development of medical devices also need to be fulfilled.
In the EU, these products are registered as medicinal products. The applicability of Medical Device Regulation (MDR) is limited to requirements on safety and performance of the device (Annex of the MDR).
In Canada, Australia and Japan, combination products are mentioned in the local regulations, regulated as either drug or device depending on the primary mode of action (PMOA).
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