¡ö Department of Medical Devices
¡õ Office for Acceptance
¡õ Division for Standards
¡õ Division of Product Registration
¡õ Division for Product Safety
¡õSecretariat of Standardization
¡ö Center for Technology Evaluation and Testing
¡ö Medical Device Divisions in Bureaus of various Provinces
¡ö China Quality Certification Center for Medical Devices
¡ö Standardization Committee

Quality Certification Center
¡¤China Quality Certification Center for Medical Devices
¡¤Requirements and filing data in application of medical device quality certification
¡¤Impartiality Statement by China Quality Certification Center for Medical Devices
¡¤Rights and duties of approved certified suppliers


China Quality Certification Center for Medical Devices

¡¡¡¡China Quality Certification Center for Medical Devices (CMDC) is a quality certification organization authorized by State Food and Drug Administration and State Quality Technology Administration and set up according to international convention and related regulations. It is an impartial third-party entity with independent legal person position, and serves to offer quality certification and quality system certification for medical device products of domestic and overseas enterprises and facilities.

¡¡¡¡CMDC executes seriously the related statutes and regulations, and plots, operates and controls according to the requirements of national approved standards of China product certification organization and national approved standards of China quality system certification organization. It is granted national approved qualification of national product certification organization from National Approved Committee of China product certification organization, with registration number of approved certificate: A01-97; and granted national approved qualification of national quality system certification organization from National Approved Committee of China quality system certification organization, with registration number of approved certificate: SC37. CMDC is the certification institution having dual national approved qualifications for executing both product quality certification and quality system certification.

¡¡¡¡CMDC is an independent operation institution, with economically independent account, independent external business, and supervised and controlled by its Controlling Committee as well as by National Approved Committee of China Product Quality Certification Organization (CNACP), and National Approved Committee of China Quality System Certification Organization (CNACR). The aims of CMDC are, by impartial, objective, scientific, superior and highly efficient quality certification, to make its contributions in offering trust to the products and quality systems approved by quality certification for enterprises; in ensuring product quality, raising the management level of enterprises, guaranteeing the safety and effectiveness of medical devices, defending the health of people, defending the legitimate rights and interests of customers, improving the competition of medical devices in domestic and overseas markets, promoting the development of international trade, and promoting international cooperation in medical device quality certification.

¡¡¡¡CMDC is to implement the responsibility system of Center director, to execute the quality systems consistent with stipulated requirements, to operate with standards, to certify according to laws, possessing all essential resources in carrying out the works of quality certification, and having a lot of medical device specialists and national registered senior accountants and accountants. It has set up a network for medical device quality certification in our whole country, and has established wide communication and cooperation with medical device quality certification communities of various countries. It has followed the tracks of dynamics in development of international medical device quality certification, keeping pace with the world level in medical device quality certification, carrying out first-class works in quality certification and creating first- class quality certification organization.

¡¡¡¡CMDC does not accept commercial, financial or other influences, does not participate any activities of certified product, such as its design, development, production, installment, supply and others, and does not offer quality certification consultation for any enterprise applying for quality certification, so as to ensure impartiality, effectiveness and authority in quality certification.

Address: No: 2 North Third Ring Middle Road, Beijing Post Code: 100011
Telephone: 62013856¡¡ 62379330¡¡ Fax£º62013872
Website£ºhttp://www.cmdc.com.cn
E-mail£ºcmdc@cmdc.com.cn Person to contact: Zhou Yajun Li Zhaohui