Chinese regulators
National Medical Products Administration (NMPA): The national authority responsible for registration and filing, overseeing regulatory oversight.
Center for Medical Device Evaluation (CMDE): Responsible for the technical evaluation of Class II and Class III medical devices, as well as imported products.
Provincial Medical Products Administration: Responsible for local management of domestic Class II registration and Class I filing.
NMPA Official Website: https://www.nmpa.gov.cn
Medical Device Registration and Filing: https://www.nmpa.gov.cn/datasearch/home-index.html#category=ylqx
Regulatory Provisions
Regulations on the Supervision and Administration of Medical Devices (Decree No. 739 of the State Council)
Measures for the Administration of Registration and Filing of Medical Devices (Decree No. 47 of the State Administration for Market Regulation)
Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (Decree No. 48 of the State Administration for Market Regulation)
Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025, effective November 1, 2026)
Rules for the Classification of Medical Devices (Announcement No. 23 of 2022 by the National Medical Products Administration)
Risk Classification
Class I (Low Risk): Subject to filing requirements; low risk level; safety and effectiveness can be ensured through routine management.
Examples: Medical examination gloves, stethoscopes, surgical scalpels, medical ice packs.
Class II (Moderate Risk): Subject to registration requirements; strict control and management are required to ensure safety and effectiveness.
Examples: Medical masks, blood pressure monitors, thermometers, electrocardiogram machines, hearing aids.
Class III (High Risk): Subject to registration management; these devices are implanted in the human body, used to support or sustain life, and pose a high risk to human health.
Examples: Pacemakers, artificial joints, vascular stents, and hemodialysis machines.
Essential Requirements for Market Access / Basis for Registration
- The product meets the definition of a medical device, and its classification is accurate (as per the classification catalog).
- The domestic registrant or filer is a legally registered corporate entity or research institution within China.
- A quality management system (QMS) compliant with GMP has been established and is effectively implemented.
- The product complies with mandatory standards and technical requirements.
- The instructions for use and labeling comply with Chinese regulations and YY/T 0469.
- The submitted documentation is authentic, complete, and traceable.
Requirements for License Holders
Domestic Registrants: Full lifecycle quality and safety responsibilities (design, manufacturing, post-market, adverse events, and recalls).
Domestic Agents: Domestic manufacturers are not required to appoint an agent; only foreign enterprises seeking registration must designate a domestic agent to assume joint and several liability.
Registration Language
Chinese
Registration Process, Timeline, and Official Fees
Registration Process: Classification Determination → Establishment and Operation of QMS → Type Testing → Clinical Evaluation → Documentation Preparation → Acceptance → Technical Review → Administrative Approval → Issuance of Certificate (some steps may not apply)
Processing Timeline
- Class I Filing: On-the-spot or within 5 working days
- Class II Registration: 3–12 months
- Class III Registration: 12–36 months
Official Fees
- Class I Filing: Free
- Class II/III Registration: Fees determined according to the latest standards set by the NMPA and the Ministry of Finance
