Medical Devices Regulatory Services
in China

Overview

China is one of the fastest-growing markets for Medical Devices, where the demand for devices is majorly met through imports. National Medical Products Administration (NMPA) (formerly CFDA) and the Centre for Medical Device Evaluation (CMDE) are responsible for the review of the Medical Device import registration applications of all the three (03) classes of devices (Class I, II & III).

Regulatory Authority: National Medical Products Administration (NMPA) (formerly CFDA)

Regulation: State Council Order No.739

Authorized Representative: China Agent Required

QMS Requirement: YY/T0287-2017, ISO 13485:2016

Assessment of Technical Data: Centre for Medical Device Evaluation (CMDE)

Labeling Requirements: Decree No.6 of CFDA

Submission Format: eRPS

Language: English & Chinese

China Medical Device Classification

The device classification is defined in the National Medical Products Administration’s (NMPA’s) Medical Device Classification Catalogue (Announcement No. 104/2017), * or/and the rules in Order No. 15 for medical devices. The devices are classified into three (03) classes based on the risk criteria. Class I devices are low-risk devices and Class III devices are high-risk devices.

Device Class

Risk

I

Low-Risk

II

Medium-Risk

III

High-Risk

China Legal Representative Services

Foreign manufacturers without a physical office in China must appoint a China Authorized Representative (CAR) to market their devices in the country. The agent is entitled to manage registration and communicate with the NMPA before and after the registration. The certificate issued by the NMPA will appear on the registration certificate. The license, however, is owned by the manufacturer.

China Medical Device Registration

Class I devices undergo administrative review, whereas Class II and Class III devices undergo a thorough review process. The data and testing requirements vary based on the availability of predicates. Hence, Class II and Class III device manufacturers should also identify predicates to determine the clinical data requirements for their devices. The NMPA issues Record Filing and Registration Certificates for Class I and Class II/III devices, respectively.

Process flow

Post Approval Device Life Cycle Management

  • Post approval change management - modifications to existing Medical Device approvals such as the addition of new variants, accessories; addition of new indications of use, among others
  • Maintenance of approvals and registration through timely payment of administrative and registration fees
  • Renewal of licenses
  • Liaising between the NMPA and the manufacturer
  • Importation management

With strong knowledge of the Chinese Regulatory landscape, Freyr guides manufacturers in successful clinical testing and the study data compilation as regulated by the NMPA. Freyr offers support in obtaining various certifications and compiling other documentation that leads to market approval within strict timelines. Freyr provides end-to-end Regulatory services for pre-and post-marketing activities of Medical Devices.

Summary

Class Registration Pathway Review NMPA Timelines Validity of Registration

Class I

Notification

Administrative Review

One (01) day

Unlimited

Class II

Registration

Full application review

1 – 2 Years

Five (05) Years

Class III

Registration

Full application review

More than two (02) Years

Five (05) Years

Expertise

Freyr Expertise

  • Regulatory due diligence for device registration with the NMPA
  • Regulatory Intelligence (RI) 
  • Product license
  • Production license
  • In-country testing, including non-clinical and clinical testing 
  • Clinical Evaluation Report (CER)
  • QMS compliance 
  • Compilation of device documents and GRP documents
  • Labeling services
  • Translation services
  • Submission and Liaising services with the NMPA
  • In-country representation 
  • Distributor identification and qualification