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