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 Centre for Medical Device Evaluation (CMDE) is responsible for the review of the Medical Device import registration applications of all the three classes of devices (Class I, II & III).

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

Regulation: State Council Order No.650

Authorized Representative: China Agent Required

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

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

Labeling Requirements: Decree No.6 of CFDA

Submission Format: Paper

Language: English & Chinese

China Medical Device Classification

The device classification is defined in National Medical Products Administration (NMPA) Medical Device Classification Catalog (Announcement No. 104/2017),* or the rules in Order No. 15 for novel devices. The devices are classified into 3 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 shall appoint China Authorized Representative (CAR) to market their devices in the country. The agent is entitled to manage registration and to communicate with the NMPA before and after registration. The certificate issued by the NMPA will appear on 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 thorough review process. The data and testing requirements vary based on availability of predicates. Hence, Class II and class III device manufacturers should also identify predicates to determine the clinical data requirements for their device. The NMPA issues Record Filing Certificate and Registration certificate 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, 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 clear-cut knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and the study data compilation as regulated by the NMPA. Freyr supports client to obtain various certifications and to compile 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

3 – 6 Months

Unlimited

Class II

Registration

Full application review

1 – 2 Years

5 years

Class III

Registration

Full application review

More than 2 years

5 years

Expertise

Freyr Expertise

  • Regulatory Due Diligence for device Registration With NMPA, China
  • Regulatory Intelligence (RI) 
  • 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 NMPA
  • In-Country Representative 
  • Distributor identification and qualification