The NMPA issued “2024 National Medical Device Clinical Evaluation Standards Project Proposals” on March 8, 2023, asking proposals by June 30, 2023. Those received thereafter were deferred to the following year.
It asks domestic and overseas manufacturers to submit the proposals on clinical trial quality management and general requirements of medical devices and IVDs. Quality management and general requirements refer to terminology, clinical trial data management, clinical trial data exchange, clinical trial data processing, real-world data for clinical evaluation, and human sample use management, etc.
Clinical requirements for specific products are not included in the planning.
Clinical Standards Proposal Requirements
- Comply with the current national laws and regulations and the relevant provisions of standardization work;
- Meet the needs of medical device supervision and technology development;
- Do not overlap or duplicate with the current national and industry standards and established planned projects;
- Comply with the national policy of adopting international standards or foreign advanced standards;
- Included in the standards of national industrial planning, major science and technology projects, etc.
About China Med Device
China Med Device provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, clinical standards, IVDs draft guidelines, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.