The NMPA clinical trial pathway for 7 categories of medical devices was updated by the Center for Medical Device Evaluation (CMDE) on June 16, 2022. The NMPA clinical trial pathway for another 8 categories of medical devices was updated on July 14, 2022.
Background
In September 2021, the National Medical Product Administration (NMPA) issued guidelines for the clinical evaluation of medical devices including the “Technical Guideline for Deciding Whether to Carry Out Clinical Trials of Medical Devices” (hereinafter referred to as the Decision-Making Guideline) which guides applicants in determining whether a clinical trial is required from three aspects:
- “high-risk medical devices”
- “new medical devices”
- “adequacy of existing evidence”.
In order to further guide applicants to determine the China clinical trial pathway of specific products, the CMDE has issued the Recommended Clinical Trial Pathways for Related Products for the following categories of the Medical Device Classification Catalogue on May 19 and June 16, 2022:
- Passive surgical devices (02)
- Neurological and cardiovascular surgical devices (03)
- Radiation therapy devices (05)
- Medical imaging devices (06)
- Medical device disinfection sterilization instruments (11)
- Active implantable devices (06)
- Passive implantable devices (13)
- Infusion, care and protective equipment (14)
- Patient-carrying apparatus (15)
- Ophthalmic devices (16)
- Dental instruments (17)
- Obstetrics and gynecology devices, assisted reproductive devices and contraceptive devices (18)
- Traditional Chinese Medicine devices (20)
- Clinical laboratory instruments (22)
The CMDE recently issued the Recommended Clinical Trial Pathways for following additional categories for the Medical Device Classification Catalogue on July 14, 2022:
- Active surgical instruments (01)
- Orthopedic surgical instruments (04)
- Medical examination and monitoring instruments (07)
- Respiratory, anesthesia and first aid equipment (08)
- Physiotherapy instruments (09)
- Blood transfusion, dialysis and cardiopulmonary bypass devices (10)
- Medical rehabilitation equipment (19)
- Medical software (21)
The Recommended Clinical Trial Pathway guidelines identifies which products do not require clinical evaluation and those that do either through predicates or through clinical trials.
Products identified as requiring “clinical trials”
Products marked with “clinical trials” the documents are usually “high-risk medical devices” and therefore a clinical trial needs to be carried out, except for the following situations:
Scenario 1
- The previous generation of the declared product has not been approved for listing in China,
- And the declared product is a design change to the previous generation of the product,
- And the applicant can prove that the declared product meets the basic principles of medical device safety and performance through the existing data (such as non-clinical research data, clinical trial data of the previous generation product, and overseas clinical data of the declared product).
Scenario 2
- The applicant may provide the overseas clinical trial data of the declared product in accordance with the requirements of the Technical Guideline for Accepting Overseas Clinical Trial Data for Medical Devices,
- And conduct a comprehensive evaluation in combination with other design verification and confirmation documents, device descriptions, instructions and labels, risk management documents and production information to prove that the declared products comply with the basic principles of medical device safety and performance.
Scenario 3
- The previous generation of the declared product has been approved for listing in China,
- And the declared product is a design change to the previous generation of the product,
- And the applicant can prove that the declared product meets the basic principles of medical device safety and performance through existing data (such as non-clinical research data, clinical data of the previous generation of products, and overseas clinical data of the declared product).
Please note: The previous generation product refers to the product that belongs to the same applicant as the declared product, has the same scope of application, and has similar technical and biological characteristics, and the declared product has an iterative relationship with the previous generation product.
Products identified with “predicate devices” and are considered “new medical devices”
If the declared product has significant differences in application scope, technical characteristics and/or biological characteristics, etc. compared with the predicate device, then it is considered a “new medical device” and clinical trials need to be carried out, except for the following situations.
Scenario 1
- The applicant can fully prove that the declared product complies with the basic principles of medical device safety and performance through non-clinical research data.
Scenario 2
- The declared product is a new type of medical device in China, but it has existing clinical data (such as overseas clinical literature data, overseas clinical trial data, etc.),
- And the applicant can prove that the declared product meets the basic principles of medical device safety and performance through non-clinical research data and existing clinical data of the declared product.
Scenario 3
- The declared product is a new type of medical device in China, but its previous generation product has overseas clinical data,
- And the declared product is a design change to the previous generation of products,
- And the applicant can fully prove that the declared product meets the basic principles of medical device safety and performance through non-clinical research data, overseas clinical data of the declared product and overseas clinical data of the previous generation of products.
Please note: New medical devices are medical devices that have significant differences in scope of application, technical characteristics and/or biological characteristics compared with medical devices that have been approved for marketing in China.
Products identified with “predicate devices” and are not considered “new medical devices”
If the products are marked with ” predicate devices” but do not belong to the “new medical devices” proposed in the “Decision-Making Guideline”, the applicant may follow the relevant requirements of:
- the Technical Guidelines for Clinical Evaluation of Medical Devices,
- the Technical Guideline for Equality Demonstration of Clinical Evaluation of Medical Devices,
- and the Technical Guideline for the Clinical Evaluation Report of Medical Device Registration.
The applicant shall select appropriate predicate devices according to the characteristics of the declared products, clinical risks, existing clinical data, etc.
In this case, if the safety and effectiveness of the differential part cannot be proved through non-clinical studies, that is, the “existing evidence cannot prove that the product complies with the basic principles of medical device safety and performance” proposed in the Decision-Making Guideline, then it may be necessary to supplement the clinical data by conducting clinical trials.
Whether a product is exempt from clinical evaluation shall be determined in accordance with the Catalogue of Medical Devices Exempted from Clinical Evaluation and its subsequent adjustments.
The CMDE is drafting more recommended clinical trial pathways for products in other categories of the Medical Device Classification Catalogue.
More Information
If you would like to know whether a China clinical trial is required for your medical device or more on our registration and CRO services, please contact Cisema.
