Medical Device Regulations in China

In China, Medical Devices are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA).

Table of Contents

REGISTRATION
Document Number Document Title Issued by Description Available Languages Download
DECREE NO. 7 Measures for Supervision and Administration of Medical Device Production CFDA Whoever engages in the production of medical devices within the territory of the People's Republic of China shall abide by DECREE NO. 7 : Measures for Supervision and Administration of Medical Device Production. English For Sale
- Announcement on Record Filling of Medical Device Master Files CFDA The record filling system of medical device master file is established in order to implement the State Council’s Opinions on Reforming the Drug and Medical Device Review and Approval System ([2015] No. 44), English For Sale
Decree No. 1 - Annex 7 Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft) CFDA In order to standardize the priority monitoring of medical device adverse events, and guide the monitoring agencies and medical institutions at all levels to monitor the sentinel and the marketing license holders to carry out priority monitoring work, and formulate the guiding principles in accordance with the “Administrative Measures for Monitoring and Reassessing Medical Device Adverse Events”. The priority monitoring of medical device adverse events (hereinafter referred to as priority monitoring) refers to the staged monitoring activities initiated to study the risk status, characteristics, severity and occurance rate of a certain medical device variety or product after listing. English For Sale
Decree No. 83 Innovative Medical Device Special Approval Procedure CFDA This procedure is stipulated to guarantee the safety and effectiveness of medical devices, encourage the research and innovation of medical devices and promote the distribution and application of new technologies of medical devices, in accordance with Regulations for the Supervision and Management of Medical Devices, Provisions for Medical Device Registration and Provisions for In-vitro Diagnostic Reagent Registration. English For Sale
Decree No. 131 Announcement on Using Chinese Name for Registrant or File Submitter of Imported Medical Devices. CFDA For further implementation of the relevant requirements, meeting public needs and accepting social supervision better, the following announcement is developed on related issues about using Chinese for the name of the registrant or file submitter for the imported medical devices. English For Sale
- Guideline for Technical Review of Medical Device Software Registration CFDA This guideline consists of general requirements for medical device software. This guideline is intended to guide manufacturers in submitting declaration data for medical device software registration and to standardize the technical review requirements for medical device software at the same time. English For Sale
- Operation Specification for Record Filing of Medical Device Master Files CFDA In order to clarify the specific requirements for the record filling application, update and transfer of medical device master files (hereinafter referred to as master files), this specification is prepared in accordance with the "Administrative Measures for the Registration of Medical Devices" and the "Administrative Measures for the Registration of IVD Reagents" as well as the actual situation of the Center. English For Sale
Guideline No. 101 Registration of Rare Disease Control Medical Devices CFDA The purpose of this guideline is to standardize the registration and approval of registered applicants and examiners for medical device products for the treatment of rare diseases, to benefit the patients, to scientifically solve the difficult points of clinical evaluation for the treatment of rare diseases, to rationally relieve the clinic, to promote the products to clinical use as soon as possible by means of conditional approval. English For Sale
- C-Reactive Protein Assay Kit Registration Technical Review Guideline CFDA This guideline is a general requirement for the C-reactive protein assay kit. This guideline is intended to guide applicants on the C-reactive protein assay kit, including the conventional C-reactive protein assay kit/supersensitive (high-sensitivity); C-reactive protein assay kit/full-range; C-reactive protein assay kit. English For Sale
RISK CLASSIFICATION
Document Number Document Title Issued by Description Available Languages Download
Order No. 15 of the State Food and Drug Administration Classification Rules for Medical Devices CFDA These rules are used to guide the formulation of medical device classification catalogues and the determination of new medical device management categories. English For Sale
LABELING
Document Number Document Title Issued by Description Available Languages Download
Decree No. 6 Regulation on Instructions for Use and Labels of Medical Devices CFDA The Regulation is enacted in accordance with the "Medical Devices Administration & Management Rules" to standardize the Instructions for Use and labels of medical devices and ensure the safety of medical device applications. English For Sale
PHARMACOVIGILANCE
Document Number Document Title Issued by Description Available Languages Download
Decree No. 1 - Annex 3 Guideline on Medical Device Adverse Event Monitoring Scope (Draft) CFDA In order to standardize the scope of medical device adverse event reports and improve the quality of the reports, this Guideline is formulated in accordance with the “Administrative Measures for Monitoring and Reassessing Medical Device Adverse Events” (Order No. 1 of the State Administration of Markets). English For Sale
Decree No. 1 - Annex 7 Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft) CFDA In order to standardize the priority monitoring of medical device adverse events, and guide the monitoring agencies and medical institutions at all levels to monitor the sentinel and the marketing license holders to carry out priority monitoring work, and formulate the guiding principles in accordance with the “Administrative Measures for Monitoring and Reassessing Medical Device Adverse Events”. The priority monitoring of medical device adverse events (hereinafter referred to as priority monitoring) refers to the staged monitoring activities initiated to study the risk status, characteristics, severity and occurance rate of a certain medical device variety or product after listing. English For Sale
DMF Registration in China video

GRP Video: Medical Device Registration in China

GRP China is authorized by the NMPA to act as your local agent and to to handle all your regulatory affairs, clinical, quality and pharmacovigilance needs in China. Check out this video to get a better understanding about our services in China for medical devices.

GRP Whitepaper: China's Green Channel pathway for innovative medical device

GRP Whitepaper: Green Channel - Priority Review Approval for medical devices

In 2018 the NMPA launched  an accelerated pathway for the examination and approval of innovative medical devices also known as Green Channel. 

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