Medical Device Registration in China

Transcription

1 IVD Medical Device Registration in China

2 Your Local Regulatory Affairs Staff-CIRS CIRS assist you Overseas Medical Devices In Vitro Diagnostic reagent Market access CFDA Registration Pre-market Approval Post-market surveillance China Market I. Regulatory Strategy for Medical Device Market Access in China Healthcare Product Is your product a medical device or in vitro diagnostic (IVD) reagent in China? Have you already applied for and obtained the appropriate license or registration certificate? Subject to other regulations? (e.g. regulations on drug, cosmetic, disinfectant, etc.) Apply for license or registration certificate update or renewal Pre-market Approval: Classification, testing, clinical trial, submission and evaluation, labeling, license for manufacturing and distributing, Customs clearance, etc. Post-market Surveillance: Quality assurance (GMP or GSP), advertisement approval, adverse event monitoring and reporting, recall, etc.

3 II. Classification of A Medical Device Medical device classification lays the foundation of the registration requirements and procedures. All class III and imported devices are managed directly by the central CFDA. Medical devices are classified in 3 classes, namely Class I, II and III medical devices. The classification system is based on the risk via integrated evaluating of intended purpose, structure features, use methods and other factors of medical device: Class I Medical devices are those with low risk degree and for which safety and effectiveness can be ensured through routine administration; Class II Medical devices are those with moderate risk and for which strict administration is required to ensure their safety and effectiveness Class III Medical devices are those with higher risk and which must be strictly controlled via special measures in respect to safety and effectiveness. III. Registration Requirements and Types for Imported Medical Devices Registration types Testing Clinical Trial Authorities Deadline Class I Record Self-testing N/A CFDA Pre-market Class II Class III Initial Registration Required Required CFDA Pre-market Updates TBA TBA CFDA Renewal TBA N/A CFDA Initial Registration Within 1months after being updated 6 months before the date of certificate expired Required Required CFDA Pre-market Updates TBA TBA CFDA Renewal TBA N/A CFDA Within 1months after being updated 6 months before the date of certificate expired

4 IV. Registration and Approval Process Classification Determined and Documents Gathered If required Appoint the Chinese Legal Representative and Service Agent Registration Strategy (Panning & Proposal) Class I Medical Devices Dossier preparation and submitted Define the Product Technical Requirements ( Former Standard ) Class II & III Medical Devices Deliver samples and Testing, Dossier preparation and submitted If required Dossier formal review and correction Clinical Trial, CSR finalized Correction Qualified Technical evaluation in Center for Administrative Service and CMDE Qualified Supplementatio n Administrative Approval and Record-keeping Issued Administrative Approval and Registration Certificate Issued Post-market Surveillance: Quality assurance (GMP or GSP), advertisement approval, adverse event monitoring and reporting, recall, etc. (more info. Can be found here:

5 V. Clinical Trail Requirements Is it Medical Devices Is it class I medical devices in China? Is it listed in the catalog of medical devices exempted from clinical trial Submission of clinical evaluation report (exemption) Does it comply with the national or industrial standard? Conduct the clinical study according to the provisions for clinical trials of medical devices in China (GCP) VI. What Can We Do for You? Aims to favor more and more abroad outstanding medical devices and technologies entering China market, CIRS leads extensive resource and establishes the full life-cycle service for your product. We start from helping you with the pre-market investigation, and there is no ending of our service:

6 Pre-market Investigation & Analysis Medical Devices Registration & Approval Clinical Trial Consulting Manufacturing and Distributing License Approval Quality Assurance & Compliance Risk Assessment & Management Customs Clearance IPR Protection in China China Medical Device Regulatory Database (CMDRD) Recall & Reevaluatio n Supervisi on & Administr ation Develop ment & Design CIRS works with you to design and implement the risk management system for the entire lifecycle of your medical device in China Registrati on & Approval Manufact ure and QMS Use Distributi on & Transmis sion Why CIRS? Qualified and experienced regulatory affairs team Full understanding of the medical device regulations Close ties with local authorities and related research institutions Full life-cycle risk management service for medical device A completely neutral third party focusing only on regulatory services Strictly respect and protect client's and proprietary interests Contact us Hangzhou CIRS Co., Ltd ADD: 11F Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou , China Tel: Fax: MD@cirs-group.com http: //