On March 23 2016 the China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules, the first revision in almost 12 years. Entitled "Good Clinical Practice for Medical Devices", the revision will become effective as of June 1 2016.
A medical device clinical study defined in the revision refers only to registration studies intended for obtaining regulatory approval. Notably, the revision does not apply to in vitro diagnostic reagents that are classified as medical devices.
The revision contains 11 chapters and 96 articles, significantly expanding the 29 articles of the existing rules. It sets out general principles as well as guidance regarding preparation before the clinical study, protection of subjects' rights, the clinical trial protocol, responsibilities of ethics committees/sponsors/investigators/sites, retention and documentation of records and reports, management of the study device and source document management. Highlights of the revision are as follows:
- Clarifying the definition of 'sponsor' – a 'sponsor' refers to the party that is responsible for the initiation, management and monitoring of a clinical study. The existing rules define a sponsor of a clinical study as the applicant that submits the device registration application, while the revision clarifies that a sponsor shall be a device manufacturer. If the sponsor is a foreign entity, such sponsor shall designate a Chinese company as its agent.
- Increasing the responsibilities of sponsors – sponsors are responsible for monitoring the study and shall appoint qualified monitors to perform monitoring activities. In addition, if there is any information affecting the study, the sponsor is responsible for revising the investigator brochure and obtaining approval from the ethics committee for the revision.
- Detailing the requirements for seeking informed consent – the revision specifies the types of information that must be included in an informed consent form and how to obtain informed consent from study subjects. Any revised informed consent forms must be approved by the ethics committee before their communication to study subjects. As long as the revision can potentially affect the subjects' willingness to participate in the study, the sponsor must seek subjects' further consent.
- Clarifying the validity of the registration test report – the study device must pass the registration type test conducted by a qualified testing centre and such type test report must be issued within one year.
- Specifying the requirements for multicentre studies – according to the revision, a 'multicentre study' is defined as a study conducted according to a single protocol, but at more than three sites. The ethics committee of the lead site shall conduct an ethics review of the protocol on behalf of all study sites. The participating sites may review the feasibility of conducting the study within the site, but generally will not propose any revisions to the protocol. The principal investigator of the lead site will become the coordinating investigator. In addition, both the coordinating investigator and the sponsor are responsible for the implementation of the entire study.
- Imposing stringent record retention requirements – the revision stipulates that the study sites must keep all clinical data and materials for 10 years after completion of the study. The sponsors must keep records of the study until all of the devices are no longer in use.
- Reiterating the study recordation requirements – reinforcing the Regulations on the Supervision and Management of the Medical Device (Order 650), the revision stipulates that sponsors shall file for the recordation of their device studies with the local food and drug administrations at the provincial level before launching any studies.
The revision will strengthen the administration of device registration studies in China. Companies intending to launch new devices in the country are advised to review their existing practices and upgrade their compliance standards to the extent necessary.
For further information on this topic please contact Katherine Wang at Ropes & Gray LLP by telephone (+86 21 6157 5200) or email (email@example.com). The Ropes & Gray LLP website can be accessed at www.ropesgray.com.
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