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Medical Device Registration
Medical Device Product Registration
Medical device registration is a drugSupervision and management departmentAccording to the application of the applicant for medical device registration, in accordance withStatutory procedures, the safety of its medical devices to be marketed,Effectivenessstudy and its results were conductedsystematic evaluationThe process of deciding whether to agree to its application.The Measures for the Administration of Registration and Filing of Medical Devices have been adopted at the 11th executive meeting of the General Administration of Market Supervision on July 22, 2021 and will come into force on October 1, 2021..
Domestic and foreign medical device manufacturers have obtained multiple product registration certificates, which can be inquired through the official website of the State Drug Administrationhttps://www.nmpa.gov.cn/datasearch/homeindex.html？itemId=ff80808183cad7500183cb66fe690285#category=ylqx
Medical device product supervision mode
The supervision and management of medical devices follow the principles of risk management, full control, scientific supervision and social co-governance. The state implements classified management of medical devices, which are divided into three categories according to the degree of risk: the first category is low risk, the second category is moderate risk, and the third category is high risk. Each type of product has the corresponding management requirements and registration, filing process.
The first category of medical devices: the implementation of product filing management
Class II and Class III medical devices: implementation of product registration management
The regulatory authorities are shown in the table below
Medical Device Product Filing/Registration Process
The filing and registration process of medical device products is a series of procedures and requirements established by the State Drug Administration to ensure the safety, effectiveness and quality control of medical devices.
1. Domestic Class I medical device filing
Submission of filing materials: Filing person to the districtMunicipal departments in charge of drug supervision and administrationSubmit filing materials.
Get Filing Number: The regulatory authority files the submitted filing information for future reference and gives the filing number.
2. Imported Class I medical devices for the record
Submission of filing materials: Filing personState Drug AdministrationSubmit filing materials.
Get Filing Number: The State Drug Administration shall file the submitted filing materials for future reference and give the filing number.
3. Registration of Class II and Class III medical devices in China
Submit Application for Registration: The applicant submits an application for registration to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the State Drug Administration.
Review: Relevant departments shall review the application materials.
Approved: After the review is passed, the medical device registration certificate will be issued.
4. Registration of imported Class II and Class III medical devices
Submit Application for RegistrationApplicant:To the State Drug AdministrationSubmit an application for registration.
ReviewThe State Drug Administration shall examine the application materials.
Approved: After the review is passed, the medical device registration certificate will be issued.
IIThree types of medical device registration application data requirements
Basis for registration of applicantThe "Measures for the Administration of Registration and Filing of Medical Devices" and other relevant laws and regulations require the preparation of registration application materials. The specific information list is as follows
OUR SERVICES
1. Domestic medical device product filing/registration service
Compliance analysis before product registration and registration strategy consultation
Product classification definition and registration scheme formulation
Compilation of product registration declaration materials
First time, change and continuation of product registration declaration
Entrusted production registration declaration under the registrant system.
Domestic Registration Declaration for Imported Overseas Medical Devices
First, change and renewal declaration of medical device production license
2. Overseas medical device product filing/registration service
medical device ce certification:Identification of applicable regulatory directives, guidance on classification and determination, and guidance on technical documentation.
Medical Device FDA Registration:Identification of applicable regulations, guidance on the preparation of registration materials, guidance on registration reporting process
Foreign products imported domestic registered agent:Undertake the role of domestic agent, product import registration declaration, regulatory communication and coordination
3.Medical Device Clinical Evaluation Services
Clinical trial counseling services:Design and preparation of clinical trial scheme, investigation and screening of clinical trial institutions, initiation of clinical trial projects (project application, ethical review, trial filing, etc.), clinical trial supervision, quality inspection, clinical data analysis and management, preparation of clinical trial reports, etc.
Comparison of clinical evaluation services of the same variety:Clinical evaluation path query planning, literature query of comparative data of the same variety, exemption of clinical comparative explanation, etc.
National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
Guangzhou: Room 201, Xinying Technology Park, No. 313 Jinxin Avenue, Panyu District, Guangzhou
Tel:400 660 1329
E-mail：nar@china-reach.net
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