China Clinical requirements
Clinical Evaluations
For the registration file in China, one of the required documents is Clinical Evaluations. Although you should have this document for your EU and US registrations, the requirements in China are slightly different.
China positions the clinical safety in between the requirements of the EU (Notified Bodies) and the US (FDA). The new acceptance criteria on clinical data are published since early 2018, while the new clinical requirements have been updated in 2021.
Three routes for clinical evaluations
There are three options to meet the clinical requirements to validate the intended product’s safety, performance and effectiveness. The selection of these three routes is based on product features, risk levels and exiting clinical data status, and shall be reviewed/updated continuously through the entire life cycles of the devices.
Option 1 Clinical Evaluation Exemption Route
NMPA formulates a Catalogue of Medical Devices Exempted from Clinical Evaluations. The Catalogue is dynamically adjusted with the technology and common cognition advancement. The products listed in this Catalogue may be exempted from the clinical evaluation report (CER) requirement.
When preparing the clinical document for products in the scope, the manufacturer needs to compare data of the intended product to the contents described in the exemption catalogue, and then compare data of the intended product with approved predicate devices in China in terms of working principle, structure, material or material directly contact the human, performance requirements, sterilization/disinfection, intended use, and use method etc.
A research/analysis report is required to address the gaps (if any) that may not impact the product’s safety and effectiveness. This option is intended for low-risk products with simpler documentation requirements. The low-risk products refer to devices with a clear mode of action, finalized design, and well-established technology. The equivalence devices shall be in the market for years without serious adverse events and without changing the standard use. Or the device’s safety and effectiveness could be proved by non-clinical evaluation.Option 2 Clinical Evaluation Route via equivalence
The equivalence option requires evaluating the intended device through one or more predicate device(s) plus comparable device(s) if needed, to compile a comprehensive clinical evaluation report. The selected predicate devices shall have already been approved in China and share the same intended use scope, and same or similar technical and biological characteristics with the intended device.
The comparable device shall share similar intended use, and technical and biological characteristics broadly with the intended devices. Sufficient scientific evidence shall be demonstrated to justify the differences. A summary document is expected to support the comparability by describing the required elements listed plus additional testing when needed to establish the comparability.
Considering many devices have been developed or modified by incremental improvement of innovation, it is encouraged to establish sufficient clinical evidence via clinical experience data and literature data of predicate/comparable/ older generation devices to support the intended product’s safety, clinical performance and/or effectiveness. The equivalence options strongly support the existing and well-established technologies such as products intended for a matured use of the technology, new generation upgrading from an older version, product modification, and products sharing the same subcontracting process.
Qserve China and CRO support for clinical evaluations
Option 3 Clinical Evaluation Route via clinical investigational study
The clinical study option is the most direct way to validate product safety and performance. Clinical investigation data is often required for the high-risk products with an extended clinical application out of the existing technology or with new material which existing clinical/non-clinical data may not be sufficient to prove its safety and effectiveness, or the innovative product with little or no experience data. A clinical study shall only be arranged to generate additional data and address the unsolved concerns or new issues.
A clinical trial refers to the study conducted by qualified medical institutions in compliance with China GCP (good clinical practice) or ISO14155, in which the safety and effectiveness of a medical device are investigated. In most cases,
a full set of clinical investigational studies including a study plan, written agreement between the sponsor and institutes, protocol, test report and EC approval shall be submitted for review.
The study can be arranged either out of China or within the Chinese mainland territory, and it can be either pre-market prospectively, or post-market retrospectively. Foreign data collection needs to meet conditions, such as adherence to the ethical principles set out in the Helsinki Declaration, scientifically sound study design, and compliance with China product-specific guidance documents. The applicant shall analyze the gaps item by item for regulatory differences between China and abroad, and prove their authenticity, reliability, scientificity, and traceability.
Clinical Requirements
How will your device meet the clinical requirements?
Let us help you to choose the appropriate selection of these three routes. Which will depend on the device and product features, risk levels and the existing clinical data status. This needs to be reviewed/updated continuously through the entire life cycles of the devices.
Contact us
Qserve CRO
Our clinical evaluation & clinical trial services
Qserve CRO is a full-service, medical device dedicated CRO and strongly believes in the value of a dedicated and practical approach for your medical device clinical activities. We are your experienced partner for:
- Pre-market clinical evaluation report
- Clinical strategy for local market access
- Comparison of technical differences with equivalent device
- Partnered local data management and CRO service
- Clinical trial protocol development and support
- Clinical trial site selection and onsite monitoring
Qserve CRO