Chindex Medical Limited (CML) is a leading provider of medical equipment. With over 1500 employees worldwide and headquarters located in China, the Company's strategy is to leverage its cross-cultural expertise to provide leading edge healthcare technologies and quality products to healthcare markets globally.
CML offers a manufacturing platforms for select medical technologies and a unique full-service distribution platform for both Western and Chinese manufacturers of medical devices. CML's expertise includes the full range of services from product registration to marketing and sales – both direct and through a closely- managed network of carefully-selected sub dealers – warehousing and sales in local currency, clinical support, installation and after-sales service provided by factory-trained engineers. CML's manufacturing platforms include several patented technologies, including proprietary energy based aesthetic devices, blood banking and transfusion equipment, wound closure products, and general surgery theater instruments.
CML offers a manufacturing platforms for select medical technologies and a unique full-service distribution platform for both Western and Chinese manufacturers of medical devices. CML’s expertise includes the full range of services from product registration to marketing and sales – both direct and through a closely-managed network of carefully-selected sub dealers – warehousing and sales in local currency, clinical support, installation and after-sales service provided by factory-trained engineers.
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Fosun Pharma 2021 Annual Results Announcement Accelerating the Globalization Comprehensively The Proportion of Revenue from Innovative Products Continues to Increase.
Fosun Pharma Announces 2020 Annual Results
Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.
Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.
After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.
MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.
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