On January 17, 2022, the NMPA (National Medical Products Administration) issued (No.3-2022) the Technical review guideline for medical device-based combination products, and the Technical review guideline for qualitative, quantitative and in vitro drug release studies on medical device-based combination products.
For the registration of combination products classified as medical device-based, the manufacturer should submit the application to the CMDE (Center for Drug Evaluation). The CMDE is mainly in charge of the technical review of medical device-based combination product applications whilst the CDE (Center for Drug Evaluation) provides support to the CMDE (more information available in our previous blog post).
Applicants are advised to pay attention to the following key items as specified in the technical review guideline for medical device-based combination products:
- Potential risks when both drugs and medical devices are being combined.
- Safety and effectiveness of medical device-based combination products should be evaluated as a single component.
- 11 special dossier requirements covering electronic filing information, product description, interaction between the medical device and drug components, drug content / dose selection, chemical and physical properties, biological properties, animal testing studies, etc.
In general, drug characterization and quanitification studies are required for medical device-based combination products, however, applicants should pay attention to the following conditions as specified in the technical review guideline for qualitative, quantitative and in vitro drug release studies on medical device-based combination products:
- Drug release studies will be required for medical device-based combination products that intend to release the drug components to certain parts of the body such as drug-eluting stents, drug coated balloon catheters, silver dressings, etc. However, drug release studies will not be required for products with different intended use such as artificial blood vessels with covalent boding of heparin, hence in vitro release studies can be carried out instead to assess the stability of the product, the firmness of the coating, etc.
- Products added with biological active substances, such as orthopedic devices containing biological active substances and devices containing heparin coating, relevant research need to be carried out according to their mechanism action, and the main components needed to be identified by quality and quantity research.
By Julie Zhang and Jacky Li. Contact Cisema if you would like to learn more.