For domestic products, submit application to local provincial drug administration; for imported products, submit application to institutes for medical device standards management.
Entrusted Testing
Entrusted Testing
Compile product technical requirements and entrust qualified medical device testing institutions to conduct the testings.
Registration Consultation
Registration Consultation
Provide consultation service for the registration and marketing of medical devices in China, the United States and the European Union, as well as consultation service for quality management system, filing of human genetic resources, and regulations.
Innovation Submission
Innovation Submission
Innovative Medical Device Application
CER
CER (Equivalent Device )
CER (Equivalent Device )
To demonstrate safety and effectiveness of the medical device through analysis and evaluation on the clinical literature data and clinical data of equivalent medical devices.
CER (Overseas Clinical Data )
CER (Overseas Clinical Data )
The conparable should have been marketed in China, which have the same scope of application, technical characteristics and biological characteristics with the product under application. This is an ongoing activities using scientifically acceptable methods to analyze and evaluate relevant clinical data to confirm the safety, clinical performance and/or effectiveness of a medical device for its intended use.
CER (Exemption from Clinical Evaluation)
CER (Exemption from Clinical Evaluation)
Provide overseas clinical trial data of the product under application according to the requirements of Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical Devices, and conduct a comprehensive evaluation using other design verification and validation documents, device description, instructions for use and labels, risk management documents and manufacturing information to prove that the product under application meets the corresponding requriements on the safety and performance of medical devices.
Clinical Trials
Medical Writing
Medical Writing
CCRC medical team providea a wide range of medical writing and medical review services for clinical studies, including the writing of study protocol, investigator’s brochure, informed consent form, and clinical study report and other documents related to the clinical trial, as well as medical review of case report form, statistical analysis plan, and statistical analysis report.
Safety Vigilance
Safety Vigilance
CCRC safety team provides safety services for the entire life cycle of medical devices from clinical study to post-marketing risk management, including but not limited to medical device safety management, submitting expedited report to regulatory authorities in China and other countries/regions, providing medical devices safety related trainings, safety systems consulting service, and assisting in establishing drug/medical devices vigilance system, etc.
Medical Monitoring
Medical Monitoring
Provide medical oversight and support for the collected clinical study data at the study level.
Clinical Monitoring
Clinical Monitoring
Upon receiving the notification of resource demand from the PM, the clinical pperations department will assign appropriate CRAs that meets the requirements for the specific project by considering the region where the site is located, project implementation requirements, personnel experience requirements and scope of work, so as to control costs, improve work efficiency, and ensure high quality by adopting strategy of nearby management and strict compliance to the project plan.
Project Management
Project Management
Clinical project management for full-service projects will be implemented by considering the three elements of time, budget and quality, which including but not limited to: participating discussion and design of the protocol by clinical experts, preparing a reasonable project execution plan, developing flexible project communication strategy and customized project reporting process, coordinating project team to deliver the work as scheduled, developing Project Management Plan to meet specific requirement of the project, and comlying with the streamlined SOP system and strong quality assurance system.
Human Genetic Resources Application
Human Genetic Resources Application
Since the implementation of the regulation on genetic resources management, CCRC RA has successfully completed electronic submission for 175 projects, and paper submission for 168 projects, among which 151 projects have been approved.
Mainly responsible for the writing of DMP, design of CRF, establishment and testing of EDC/IWRS, data cleaning, external data management, medical coding, database locking, and daily data query answering, etc.
Translation
Translation
Mainly responsible for the translation of medical device clinical trial and other registration documents, including clinical study protocol, investigator’s brochure, informed consent form, clinical study report, case report form, statistical analysis plan, statistical analysis report, clinical evaluation report, and medical literatures, etc.
Filing in provincial drug administration
Filing in provincial drug administration
Preparation before the implementation of the clinical trial: The sponsor shall file at the drug regulatory authority of the province, autonomous region or municipality directly under the central government .
On-site inspection
On-site inspection
Responsible for quality control throughout the project process within the company. Conduct on-site inspection according to the quality control plan of the project, and and assist in completing the rectification of problems and formulate preventive measures.
SMO
SMO
Dedicated to SMO operation management of medical device and drug clinical trial projects in therapeutic fields including neurointervention, cardiovascular intervention, tumor intervention, respiratory intervention, artificial intelligence, robotics, and oral cavity.
Regulatory Submissions
Registration Submission
Registration Submission
Preparation and submission of registration application dossiers.
Supplemental Submission Support
Supplemental Submission Support
Assist the applicants/registrants to complete the submission of supplementary materials according to the requirements in the Notice on Supplementation.
Renewal or Change of Registration Certificate
Renewal or Change of Registration Certificate
Renewal of registration certificate: apply for registration renewal to the drug regulatory authority 6 months prior to the expiration of the medical device registration certificate, and submit the application dossiers according to relevant requirements; Change of registration certificate: For a registered Class II or Class III medical device, if there are substantial changes in the design, raw materials, manufacturing process, scope of application, and usage, which may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for change of registration; if there are other changes, this shall be filed or reported in accordance with the provisions of the drug regulatory authority under the State Council.
Post-Marketing Studies
Real-World Studies
Real-World Studies
Help to promote the landing of importing of international innovative device products and application of real-world studies for the international innovative device products in Hainan Boao Lecheng International Medical Tourism Pilot Zone.
Investigator-initiated Clinical Studies
Investigator-initiated Clinical Studies
Support the medical and health institutions to carry out activities to study the diagnosis, treatment, rehabilitation, prognosis, etiology, prevention of diseases and health maintenance by taking individual or group of human subjects (including medical and health information) as the study subjects but not aiming at the registration of any drug or medical device.
