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 |
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: 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.