With the development of the medical technology, the NMPA(CFDA) started to strengthen the management of the combination products.
In 2018, CFDA held a symposium on “Preliminary attribute definition and evaluation and approval of combination products”, discussed the present difficulties in the attribute definition and evaluation and approval of drug-device combination products and international administration models. In the symposium, the experts suggested to establish a definition office and add channels for communication in the process of definition, emphasized to conduct joint evaluation, joint risk identification, joint post-marketing monitoring and re-evaluation, and joint evaluation of the safety and effectiveness of the product throughout the entire life cycle.
Improve Definition Process
- Open consultation channels before acceptance and encourage early consultation on R&D.
- Encourage early definition on R&D, avoiding non-compliance of reporting paths and registration materials, and reducing the burden on applicants.
- Announce of the results of the previous definition, guiding the applicant to declare properly.
Comparison of definitions of drug-device combination products between the FDA 21 CFR 3.2(e) and China.
|1. Drug and/or biological product + devices|
|2. Drug + biological product|
|4. Specified by clinical research to be used together|
|5. Specified by IFU to be used together|
China’s definition of the combination product is in Bold. The scope is much smaller than the US’s definition.
Common problems in the application dossier: regulate application dossier for attribute definition
Since China and the United States have different definitions for the combination products, the following problems will occur during the application of the attribute definition process.
- The regulatory methods and predicate products at home and abroad are not clarified.
- Whether the basis of the combination product is sufficient.
- Lack of supporting materials for the mechanism of action and the main mode of action of the product.
- The combination mode of the drug and the device in the product is not clarified.
- The method of steps of using the product is not clarified.
How to avoid these problems during the application process? Please contact ChinaMedDevice, LLC to learn more services of combination products.
For more information about the combination products in China, please email info@ChinaMedDevice.com.
About China Med Device, LLC
China Med Device, LLC (https://ChinaMedDevice.com/) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.