Service Scope

Preclinical

Classification Identification

Category Identification

For domestic products, submit an application to local provincial drug administration; for imported products, submit an application to the Institute for Medical Device Standardization Administration.

Entrusted Testing

Prepare product technical requirements and entrust qualified medical device testing facilities to conduct the tests.

Registration Consultation

Provide consultation services for the registration and marketing of medical devices in China, the United States and the European Union, as well as consultation services for quality management system, filing of human genetic resources, and regulations.

Innovation Submission

Innovative Medical Device Application

Clinical Evaluation Reports (CER)

CER (Equivalent Devices)

Devices

Demonstrate the safety and efficacy of the medical device through analysis and evaluation of clinical literature and clinical data of equivalent devices.

CER (Overseas Clinical Data)

The device under application should have the same scope of application, technical features, and biological characteristics as those of predicate devices. This is an ongoing activity using scientifically acceptable methods to analyze and evaluate relevant clinical data to confirm the safety, clinical performance and/or efficacy of a medical device for its intended use.

CER (Exemption from Clinical Evaluation)

Provide overseas clinical trial data of the product under application according to the requirements of the 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 requirements on the safety and performance of medical devices.

Clinical Trials

Medical Writing

The CCRC medical team provides a wide range of medical writing and medical review services for clinical studies, including the writing of clinical study protocols (CSP), investigator’s brochures (IB), informed consent forms (ICF), clinical study reports (CSR) and other documents related to the clinical trials, as well as medical review of case report forms (CRF), statistical analysis plans (SAP), and statistical analysis reports (SAR).

Safety Vigilance

The 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, submission of expedited reports to regulatory authorities in China and other countries/regions, provision of medical device safety related trainings, safety system consultation, and assistance in establishing drug/medical device vigilance systems, etc.

Medical Monitoring

Provide medical oversight and support for the collected clinical study data at the study level.

Clinical Monitoring

Upon receiving the notification of resource demand from the Project Manager (PM), the Clinical Operations Department will assign appropriate Clinical Research Associates (CRA) that meet 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 adoption of the principle of proximity management and strict compliance with the project plan.

Project Management

Management of full-service projects will be implemented in consideration of time, budget and quality, including but not limited to:
· Participation in the discussion and design of the protocol by clinical experts;
· Preparation of a reasonable project execution plan;
· Generation of a flexible project communication strategy;
· Formulation of a customized project reporting process;
· Coordination with the project team to deliver the work as scheduled;
· Development of a project management plan that can satisfy the project-specific requirements;
· Establishment of a complete SOP system and a robust quality assurance system.

Application for Human Genetic Resources

Since the implementation of the Regulations of the People’s Republic of China on Administration of Human Genetic Resources, CCRC Regulatory Affairs (RA) has successfully completed electronic submission for 175 projects, and paper submission for 168 projects, among which 151 projects have been approved.

Imaging Core Lab

Services including Quantitative Coronary Angiography (QCA) Core Lab, Intravascular Ultrasound (IVUS) Core Lab, Optical Coherence Tomography (OCT) Core Lab, Peripheral Vascular Analysis; Neurointerventional Imaging Core Lab, and Valve Core Lab (TAVR)

Data Management

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

Mainly responsible for the translation of medical device clinical trials and other registration documents, including CSPs, IBs, ICFs, CSRs, CRFs, SAPs, SARs, and medical literatures.

Filling with Provincial Medical Products Adminstration

Preparation before the implementation of the clinical trial: The sponsor shall file with the medical products administration of the province, autonomous region or municipality directly under the central government where the sponsor is located.

On-site Inspections

Responsible for quality control throughout the project process within the company. Conduct on-site inspections according to the quality control plan of the project, and assist in completing the rectification of problems and formulate preventive measures.

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

Prepare and submit registration application dossiers.

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 of registration certificate: Apply for registration renewal to the medical products administration 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 efficacy of the medical device, an application for registration change shall be submitted by the applicant to the original registration authority; if there are other changes, the changes shall be filed or reported in accordance with the provisions of the National Medical Products Administration (NMPA) under the State Council.

Post-Marketing Studies

Real-World Studies

Assist in promoting the import 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

Support healthcare institutions to conduct studies in the disease diagnosis, treatment, rehabilitation, prognosis, etiology, prevention and health maintenance by taking individuals or population groups (including medical and health information) as the study subjects but not aiming at the registration of any medical product.

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Service Scope

Preclinical

Classification Identification

Entrusted Testing

Registration Consultation

Innovation Submission

Clinical Evaluation Reports (CER)

CER (Equivalent Devices)

CER (Overseas Clinical Data)

CER (Exemption from Clinical Evaluation)

Clinical Trials

Medical Writing

Safety Vigilance

Medical Monitoring

Clinical Monitoring

Project Management

Application for Human Genetic Resources

Imaging Core Lab

Data Management

Translation

Filling with Provincial Medical Products Adminstration

On-site Inspections

SMO

Regulatory Submissions

Registration Submission

Supplemental Submission Support

Renewal or Change of Registration Certificate

Post-Marketing Studies

Real-World Studies

Investigator-initiated Clinical Studies

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