China Medical Device Standards

Monitoring requirements and evaluation of sterilization effect of small pressure steam sterilizer

Issued

2026-07-30

Effective

2027-02-01

Artificial intelligence medical device—Quality requirements and evaluation—Part 1: Terminology

Issued

2026-07-30

Effective

2027-08-01

Requirements for development, validation and routine control of cleaning process for medical devices

Issued

2026-01-28

Effective

2027-08-01

Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards

Issued

2026-01-28

Effective

2027-02-01

Sterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices

Issued

2025-12-02

Effective

2029-01-01

Specification for Smart Health Management and Service Evaluation in Integrated Healthcare and Wellness

Issued

2025-10-30

Effective

2025-11-01

Evaluation Criteria for Chief Quality Officer (CQO) of Medical Devices

Issued

2025-07-08

Effective

2025-08-01

Sterilization of medical devices—Guidance on using parametric release for ethylene oxide sterilization process

Issued

2024-10-26

Effective

2026-11-01

Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

Issued

2024-08-23

Effective

2027-09-01