1. Guidelines for registration and review of drug-device combination products, which mainly function as medical devices:
(1) Scope of application: Drug-device combination products refer to medical products that are composed of drugs and medical devices and are produced as a single entity. Among them, drug-device combination products, which mainly function as medical devices, and which further are managed as medical devices, are referred to as “drug-device combination medical devices”.
(2) Basic requirements: Usually drug-device combination medical devices focus on the safety and efficacy of local application of drugs. However, when the blood concentration of the drug after combined application is greater than that of conventional drugs, systemic toxicity should also be evaluated.
(3) List of Special Requirements:
① eRPS Requirements: Submit drug-related product description, drug and/or medical device-drug interaction, drug content/dose selection information in CH 3.8 (Other Information). At the same time, submit relevant research summaries in CH 3.8. If specific research materials are submitted in other eRPS projects, the corresponding eRPS project number and file name should be specified.
② Product Description: The applicant needs to describe in detail the name of the drug in the drug-device combination medical device product, the intended purpose of use, the primary mode of action, the source, and relevant licensing documents (if any).
③ Medical Device and Drug Interactions
④ Drug content/dose selection
⑤ Chemical and physical properties
⑥ Biological properties
⑦ Animal research
⑧ Stability study
⑨ Product technical requirements
⑩ Manufacturing information
(4) Clinical evaluation requirements: Before conducting clinical evaluation, applicants are advised to clarify the clinical mechanism of action, intended use, possible risks, and possible adverse events of the combination product, and fully consider them during clinical evaluation.
2. Guidelines for the registration and review of qualitative, quantitative, and in vitro release studies of drugs in drug-device combination products mainly functioning as medical devices
(1) Scope of application: This guideline is applicable to the qualitative, quantitative, and in vitro drug release studies of drug-device combination medical devices. Products that work by delivering the drug to the intended site (e.g., slow, controlled, or other releases), such as Layered stents, medicated balloon dilatation catheters, silver-containing dressings, etc., need to conduct in vitro drug release studies.
(2) In vitro drug release: under appropriate conditions, the drug in vitro release rate and release amount test of the drug-device combination medical device.
(3) Methodological validation: According to the research purpose, the validation indicators that may be required include specificity, accuracy, precision, detection limit, quantification limit, linearity, range, durability, etc. Matrix effects need to be considered during method development and validation.
(4) Report content: The research report generally includes the test discussion, test plan, and test report.