Overview China is the fastest growing market for Medical Devices whose major share of device demand is met through exports. China Food and Drug Administration’s (CFDA’s) arm Centre for Medical Device Evaluation (CMDE) is responsible for the review of the medical device import registration applications of all 3 classes of devices (Class I, II & III). Devices of Class II and III require clinical data post testing from CFDA accredited labs whose approval can take up to 2 years. Free Sale Certification from country of origin, ISO 13485 Certification and procurement of multiple obligatory documents set to be more roadblocks, slowing down the process amid time-bound situations. Freyr prepares client for compliance to obtain various certifications and other documentation that leads to market approval within strict timelines. With knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and its study data compilation in manner prescribed by CFDA. We also offer local representation and a full-circle Regulatory services for medical device manufacturers. China Market Entry for Medical Devices - Process Flow Freyr Expertise Regulatory Assistance for Registration Medical Device Classification Clinical Trial Support Chinese Local Agent Representation Testing Data and Dossier/Documents Compilation Assistance for Listing Product Technical Specifications Linguistic Translation Support for all Submission Documents Post-Market Surveillance Summary S. No Regulatory Parameter China 1 Regulatory Authority CFDA 2 Regulation State Council Order No.650 3 Risk Classification Class I Class II Class III 4 Regulatory Pathway Class I Notification Class II & III Registration 5 Authorized Representative China Agent required 6 Fee payable Class I No Fee Class II ~ $34,000* Class III ~ $ 48,000* 7 QMS Requirement YY/T0287-2017 ISO 13485 8 Assessment of Technical Data Center for Medical Device Evaluation (CMDE) 9 Validity of License Class I Unlimited Class II & III 5 Years 10 Labelling Requirements Decree No.6 of CFDA 11 Submission format Paper 12 Final Outcome Class I Notification Class II & III Registration Certificate 13 Timelines Class I 3 -6 months Class II 1 - 2 years Class III More than 2 years 14 Language English & Chinese *The price is as per records at the time of documentation and is subject to change.