The Chinese State Food and Drug Administration (“SFDA”) published the revised Medical Device Good Clinical Practice (“Medical Device GCP”) in late August and is soliciting public comments until September 30, 2012. The current Medical Device GCP, with only 29 articles in seven chapters, is a compilation of high-level principles for the conduct of clinical studies. The revised Medical Device GCP significantly expands its coverage to 103 articles in 11 chapters and contains much more detailed operational guidance.
Unlike the current Medical Device GCP which mainly addresses the responsibilities of key stakeholders involved in a clinical study, i.e. the study subjects, sponsor, sites and investigators, the revised Medical Device GCP focuses on the operational flow of a clinical study and specifies clear requirements for all aspects of the conduct of a clinical study, including pre-study preparation and necessary conditions, protection of rights and interests of study subjects, clinical study protocol, responsibilities of an ethics committee, responsibilities of the sponsor, responsibilities of study sites and investigators, records retention, administration of study devices and administration of study-related basic documents. Highlights of the revised Medical Device GCP include the following:
- The revised Medical Device GCP is only intended for in vivo clinical studies and does not apply to in vitro diagnostics classified as medical devices. Furthermore, it is only intended for registration studies and does not apply to clinical studies not intended for regulatory approvals, e.g. investigator-sponsored studies.
- Clinical studies of medical devices currently do not require any prior approval from SFDA. The revised Medical Device GCP requires an advanced approval by SFDA for high risk medical devices, a catalogue of which to be further defined by SFDA. Clinical studies of medical devices not listed in the high risk catalogue shall be recorded with the provincial FDAs where the sponsor is located.
- The current Medical Device GCP requires a self-test report and a testing report issued by SFDA-designated testing institutes before the initiation of a clinical study. Data derived from animal tests are mandatory if the study device is an implant. Under the revised Medical Device GCP, pre-clinical study is mandatory and shall cover structural composition of the study device, operational mechanism, intended use, intended scope of application, manufacturing technique and results of quality tests (including self-test reports and testing reports issued by the SFDA-designated testing institutes). The study device shall be manufactured at a site compliant with applicable medical device Good Manufacturing Practice requirements.
- Under the current Medical Device GCP, sponsors of clinical studies involving imported medical devices are the overseas manufacturers of said imported devices. The revised Medical Device GCP allows sponsors to be a company, institution or organization, but if the sponsor is a foreign legal entity, an independent legal entity in China needs to be named as the foreign sponsor’s agent and assumes all regulatory responsibilities of the sponsor.
- While the current Medical Device GCP sets forth the primary responsibilities of a sponsor of a clinical study, the revised Medical Device GCP further stipulates the operational details. For example, the sponsor shall arrange inspections and audits on the study sites to ensure full compliance with the relevant laws and regulations, the study protocol and study-related standard operating procedures (“SOPs”). The sponsor shall prepare an investigator brochure and the necessary information to be contained therein is defined in the revised Medical Device GCP. Last but not least, the sponsor shall package, label, store and distribute the study devices in accordance with the revised Medical Device GCP and provide the sites and investigators with a SOP governing the transportation, receipt, storage, processing, dispensing and recycling of the study devices to ensure appropriate quality assurance.
- To better protect the interests and benefits of study subjects, in addition to expanding the necessary information to be included in the informed consent form, the revised Medical Device GCP also specifies the circumstances under which informed consent may not be obtained from the study subjects themselves but their legal representatives or guardians.
- The revised Medical Device GCP expands the scope of necessary information to be elaborated in the study protocol, particularly in relation to study design, evaluation criteria for safety and efficacy, and process for amending the study protocol. In addition, the necessary information to be contained in the study report is explicitly itemized in the revised Medical Device GCP.
- The composition and responsibilities of the ethics committee have not been addressed in the current Medical Device GCP. The revised Medical Device GCP closes this statutory loophole by specifying the statutory requirements in relation to the ethics committee. Notably, any change in the informed consent form or study protocol requires an approval by the relevant ethics committee.
- The notion of a multi-center clinical study is not clearly defined in the current Medical Device GCP, despite of its prevalence in practice. The revised Medical Device GCP provides a definition of the multi-center clinical study and stipulates the basic operational mechanism for running a multi-center clinical study, e.g. the division of duties between the lead site/primary investigator and other study sites/investigators and the coordination of ethics committee review at multiple sites.
- To ensure data integrity, the revised Medical Device GCP stipulates the necessary information to be included in the case report form and prohibits any modification of the original clinical study record. Changes to the original record can only be made as additional narratives.
Although the revised Medical Device GCP intends to significantly raise the bar for the conduct of clinical studies in China, multinational medical device manufacturers may be less affected compared to their Chinese peers because the standards adopted by their internal policies and SOPs have already surpassed existing regulatory requirements under the Chinese law. However, multinational medical device manufacturers are strongly encouraged to carefully review and comment on the draft revision in order to minimize unfavorable operational impacts.