GB 16174.1-2024
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
手术植入物 有源植入式医疗器械 第1部分：安全、标记和制造商所提供信息的通用要求
Explanation
GB 16174.1-2024 is an upcoming mandatory Chinese national standard for Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Sep 1, 2027.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Verify against the official source before using this record in a compliance decision.
Applicability hints
- Type
- Foundational
- CCS
- C30
- ICS
- 11.040.40
- Competent department
- National Medical Products Administration
- Technical committee
- National Technical Committee on Surgical Implants and Orthopedic Instruments of Standardization Administration of China