1. Supervision of drug-containing medical devices
Drug-containing medical devices in this article refer to products that come with clear attribute definition and are managed by products that combine drugs and devices but are mainly used as medical devices. Such products do not include products used for interface disinfection, such as alcohol swabs, as well as those containing new chemicals as the drug. (With respect to the evaluation of the safety and efficiency of the new chemical, more factors should be taken into consideration). Drug-containing medical devices are quite different from ordinary medical devices in terms of raw materials, production process, and product performance. Given that they belong to different registration units, it is recommended to submit application and register the devices seperately.
2. Main types of drug-containing medical devices
Based on how drugs and devices are combined, drug-containing medical devices can be divided into two types: one: drugs act as coatings for devices, such as extracorporeal circulation tubes, intravenous catheters, urethral catheters, patches and medical gloves that come with drug coatings. Two: drugs are used as material components of medical devices, such as a drug-impregnated intravenous catheters and cerebrospinal fluid bypass tubes, as well as orthopedic/oral filling material, dressings, in vitro reproductive products, and medical sutures that contain drugs.
3. Focuses of safety and effectiveness evaluation on research data of drug-containing medical devices
3.1 Whether attributes of products have changed?
After drugs are added, the management category and attributes of corresponding devices may change. For example, if products managed as Class II medical device, after drugs are added, turn into products that combine drugs and devices but are mainly used as medical devices, such products shall be applied as Class III medical devices. It is worth noting that main function of some products change after drugs are added and the attributes of such products experience a change as a result. These products shall not be managed as medical devices, such as such as liquid dressings, gel dressings, nasal sprays and other products. CFDA has repeatedly issued papers that require such products not be managed as medical devices.
3.2 Basis for application of products
Applicants need to specify the name, supplier, marketing certificate, quality control requirements, amount of additives, the way drugs are combined with devices, releasing mode and release amount of the added drugs in the application materials. In addition, mechanisms and modes of action and the basis of action of products should be clarified. And the applicants need to submit an efficacy comparison report between drug-containing devices and ordinary devices and submit sufficient research data to prove that the benefits of adding drugs outweigh the risks. If the administration/exposure route and exposure dose of drugs added to the device is similar to those when such drugs are marketed only as drug, applicants are recommended to submit research data on safety and efficacy regarding relevant drugs in the application materials for reference by the reviewers. If similar devices with the drug have been marketed, it is also recommended that applicants submit relevant reference materials.
3.3 Consideration of new risks to products after drugs are added
After drugs are added to the devices, new risks to products should be taken into consideration.
4. Conclusion
Drug-containing medical devices have been enjoying a rapid growth with a rising number of products both internationally and domestically. Due to the diversity and complexity of such products, regulatory authorities and technical review departments have been refining the regulatory concepts and requirements of technical review of such products.
Drug-containing medical devices in this article refer to products that come with clear attribute definition and are managed by products that combine drugs and devices but are mainly used as medical devices. Such products do not include products used for interface disinfection, such as alcohol swabs, as well as those containing new chemicals as the drug. (With respect to the evaluation of the safety and efficiency of the new chemical, more factors should be taken into consideration). Drug-containing medical devices are quite different from ordinary medical devices in terms of raw materials, production process, and product performance. Given that they belong to different registration units, it is recommended to submit application and register the devices seperately.
2. Main types of drug-containing medical devices
Based on how drugs and devices are combined, drug-containing medical devices can be divided into two types: one: drugs act as coatings for devices, such as extracorporeal circulation tubes, intravenous catheters, urethral catheters, patches and medical gloves that come with drug coatings. Two: drugs are used as material components of medical devices, such as a drug-impregnated intravenous catheters and cerebrospinal fluid bypass tubes, as well as orthopedic/oral filling material, dressings, in vitro reproductive products, and medical sutures that contain drugs.
3. Focuses of safety and effectiveness evaluation on research data of drug-containing medical devices
3.1 Whether attributes of products have changed?
After drugs are added, the management category and attributes of corresponding devices may change. For example, if products managed as Class II medical device, after drugs are added, turn into products that combine drugs and devices but are mainly used as medical devices, such products shall be applied as Class III medical devices. It is worth noting that main function of some products change after drugs are added and the attributes of such products experience a change as a result. These products shall not be managed as medical devices, such as such as liquid dressings, gel dressings, nasal sprays and other products. CFDA has repeatedly issued papers that require such products not be managed as medical devices.
3.2 Basis for application of products
Applicants need to specify the name, supplier, marketing certificate, quality control requirements, amount of additives, the way drugs are combined with devices, releasing mode and release amount of the added drugs in the application materials. In addition, mechanisms and modes of action and the basis of action of products should be clarified. And the applicants need to submit an efficacy comparison report between drug-containing devices and ordinary devices and submit sufficient research data to prove that the benefits of adding drugs outweigh the risks. If the administration/exposure route and exposure dose of drugs added to the device is similar to those when such drugs are marketed only as drug, applicants are recommended to submit research data on safety and efficacy regarding relevant drugs in the application materials for reference by the reviewers. If similar devices with the drug have been marketed, it is also recommended that applicants submit relevant reference materials.
3.3 Consideration of new risks to products after drugs are added
After drugs are added to the devices, new risks to products should be taken into consideration.
4. Conclusion
Drug-containing medical devices have been enjoying a rapid growth with a rising number of products both internationally and domestically. Due to the diversity and complexity of such products, regulatory authorities and technical review departments have been refining the regulatory concepts and requirements of technical review of such products.