On March 23, 2016, the CFDA has released its Quality Management Regulations for Medical Device Clinical Trials (CFDA Decree 2016 No, 25). The Regulations will come into effect on June 1, 2016.
1. The formulation background of the Regulations
In 2004, the former SFDA released the Provisions for Medical Device Clinical Trials. However, with the increasing knowledge of the medical device clinical trials, the Provisions became challenging to manage the current situations of the medical device clinical trials.
Based on the previous thorough research on the relevant management situations of clinical trials at home and abroad, considering China’s national conditions and opinions from various parties, after repeated discussions and revisions, the formulation of the Regulations is finally completed in accordance with the Article 18 of the Regulations for the Supervision and Administration of Medical Devices.
2. The applicable scope of the Regulations
The clinical trials of the medical devices mentioned in the Regulations are referring to the process of confirming or verifying the safety and effectiveness of the medical devices that are intended to apply for registration under normal operating conditions. The medical device clinical trials in People’s Republic of China shall comply with the Regulations. However, the Regulations are not applicable to the IVD reagents in accordance with the management of the medical devices.
3. The main content of the Regulations
There are 11 chapters and 96 articles in the Regulations that cover the whole process of medical device clinical trials, including design, implement, supervision, verification and inspection of the clinical trialprotocols as well as the collection, recording, analysing, summarising and reporting of data, etc.
Chapter I is the General Provisions with 5 articles in total, which specify the legislative purpose and basis and the applicable scope, as well as clarify the duties of all supervision departments.
Chapter II is the Pre-preparation for Clinical Trials with 7 articles in total which clarify the required conditions of software and hardware to start the medical device clinical trials.
Chapter III is the Protection of Rights and Interests of Testing Subjects with 13 articles in total which specify subjects’lawful rights and interests under protection. It is clearly stated that the ethical review and informed consent are the main measures for protecting subjects’ rights and interests.
Chapter IV is the Protocol of Clinical Trials with 4 articles in total which specify the organisation and formulation, content and revision, and other aspects of the clinical trial protocol.
Chapter V is the Responsibilities of Ethics Committee with 8 articles in total which illustrate the constitution, structures, work procedures, responsibilities, deliberation-required key points and other content of the Ethics Committee.
Chapter VI is the Responsibilities of Sponsors with 21 articles in total which specify sponsors’ main responsibilities and the provided documents.
Chapter VII is the Responsibilities of Institutions and Researchers of Clinical Trials with 21 articles in total which specify the qualification criteria for the researchers, particularly stating that the relevant measures should be employed by the researchers to protect subjects’ life and health and safeguard subjects’ rights.
Chapter VIII is Recording and Reporting with 7 articles in total which list the requirements for recording the process of the clinical trials and for compiling reports of the clinical trials.
Chapter IX is the Management of Medical Devices for Trials with 3 articles in total which specify labeling, recording and using of the medical devices for the trials.
Chapter X is the Basic Document Management with 3 articles in total which specify the regulations on safekeeping of relevant documents formed before, during and after the medical device clinical trials.
Chapter XI is the Supplementary Provisions with 4 articles in total which are used to specify the meanings of some terms, the explanations of specific events, dates of implementation and other matters.
4. The main differences between the Regulations and the former Provisions
- The Regulations abolished the requirement in which “the medical device clinical trials are divided into the clinical trial use and the clinical verification of the medical devices”. For the new products that are not yet approved for sale at home and abroad, feasibility tests should be conducted in a small sample size, and then depending on the situations, safety and effectiveness tests can be conducted in a larger sample size.
- The Regulations had clarified the supervision responsibilities and implemented regulations on the requirements for record and approval. During the “approval” process, for the Class III medical devices that are listed in the Clinical Trial Approval-Required catalog, their clinical trials can only be conducted upon the approval of the CFDA.
- The Regulations clarified that “the development of the medical devices for trials should conform to the relevant requirements of the quality management system of medical devices”.
- The Regulations emphasizes on the protection of subjects’ rights and interests. It has clarified the constitution, responsibilities, and approval requirements of the Ethics Committee. Informing the subjects for their consent should be strictly enforced, and the content of the informed consent form and the methods and requirements of the informed consent are clarified.
- The Regulations have put forth the concept of multi-centre clinical trials and set up multiple detailed requirements for the design and implementation of the protocol.
- The Regulations have strengthened the responsibilities and obligations of all parties in the clinical trials. The sponsors are responsible for initiating and applying, organising and inspecting the clinical trials, and are responsible for the authenticity and reliability of the clinical trials; the Ethics Committee should fulfill their duty of reviewing and supervising the implementation of the trials; the institutions and researchers of the clinical trials should conduct the clinical trials in accordance with the relevant regulations, timely report when adverse events occur and employ appropriate therapeutic measures.
- The Regulations have introduced the concept of device defects and specified the handling and reporting process of the device defects.
- The Regulations have improved the management requirements for clinical trial recording, the medical devices for trials, the basic documents and other steps.
5. The supportive documents of the Regulations
In order to further regulate the process of medical device clinical trials, the CFDA has also formulated 6 supportive documents to be implemented along with the Regulations simultaneously after being released.