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GROUP PROFILE
Company Profile

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.  The R&D and manufacturing processes utilized globally are at market leading, international levels. CML’s manufactured products are sold in more than 70 countries in Asia, Europe and the Americas.


CML’s distribution services in China are focused in core areas of Aesthetics, Imaging, Surgery, Dermatology, Oncology and Dental, with strategic expansion into new sectors planned in the near term.  CML currently provides exclusive distribution services to, EOS system, Neurologica’s CereTom and BodyTom CT scanners, Xoft interoperative radiotherapy equipment, ARTAS Hair Restoration System, CNAP Monitor, Narcotrend. CML provides distribution services to, Mitaka Kohki’s surgical microscopes, Anatomage Table.


Huayin Medical Devices, a CML company, is the largest manufacturer and exporter of surgical blades and surgical sutures with needles (absorbable and non-absorbable) in China.  Alma Lasers, the world leader the design and manufacturer of energy based aesthetic devices, was added to the CML family of companies in 2014. 

 

F A Q
Is it legal for manufacturers to cope with issues of initial registration without an agent ?

 

 

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.

In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?

 

 

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.

 

How long is the NMPA review process for the initial registration of the medical device ?

 

 

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.

 

Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?

 

 

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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