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Department of Science, Technology and Standards
To organize and implement major science and technology programs for food and drug supervision, accelerate the construction of food and drug testing system, electronic supervision tracking system, and information system; to draft qualification requirements and testing norms governing food and drug testing institutions, and supervise their implementation; to organize the drafting of standards for drugs, medical devices, cosmetics, and catalogues, pharmaceutical use requirements, standards for immediate packaging materials and containers, and participate in the drafting of food safety standards.
system
3
Control of all life cycle
MD life cycle＝R&D－Manufacture －sales－use－service－disposal
Before market
Products registration Manufacturer approved
Post market
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Department of Medical Device Registration
❖ To conduct registration for Class III and import medical devices in strict accordance with the conditions and procedures prescribed by law, take the correspondent responsibilities, optimize registration control procedures, organize and implement classification administration, and supervise the implementation of good practices for medical devices.
Division of
Monitoring ands
Manufacturing Supervision
Distribution Supervision
Registration I
Registration II
General Affairs
Research Supervision
----Testing Capacity
➢As a national medical device testing center, BIMT undertakes the assignments such as registration testing, supervision sampling testing of medical device testing, CCC compulsory safety certification testing, testing of import & export commodities, certification testing, entrusted testing and arbitration testing in and out of China.
---Brief Introduction of BIMT
➢BIMT, with its former name Beijing Medical Device Testing Station , was established in 1983 and it was attached to the former Beijing Medical Equipment Institute. ➢BIMT has reformed into a public institution with independent judicial person since 2000, which was an affiliate of BJDA . ➢Same time It is a subordinate agency of SFDA.
Import& Export
Entrust
…
Registration
Supervision
Certification
Content
1.Present situation of CFDA 2. Present medical device regulations
system 3. Present medical device standards
Surveillance for products： such as sampling testing, Recall,Adverse events.
Surveillance for behaviors (GMP): Such as quality systems, distribution,use,disposal
4
Present situation of CFDA
China food and drug administration
Department of Medical Device Registration
Department of Medical Device supervision
Department of Science, Technology and Standards
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Department of Medical Device Supervision
❖ To track and analyze medical device safety situation and existing problems, and to put forward recommendations on system, mechanism and performance improvement; to supervise the lowlevel administrative departments in conducting administrative licensing by law, in performing the administrative duty, in detecting and rectifying illegal and improper acts in time; to organize and conduct medical device adverse events monitoring and reevaluation.