11
2014
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03
CFDA says comprehensive revision of medical device regulations this year
On March 4, officials of the State Food and Drug Administration said at the forum of representatives of the two sessions of the pharmaceutical industry that the documents, regulations and regulations on medical devices will be comprehensively revised this year. Industry insiders said that in February, the executive meeting of the State Council just deliberated and passed the "Regulations on the supervision and administration of medical devices (Revised Draft)" (hereinafter referred to as the "draft"), and these amendments should be carried out around this "draft.
On February 12, Premier Li Keqiang of the State Council deliberated and passed the above-mentioned "Draft" at the executive meeting. This "late" revised regulation will be officially promulgated after 7 years. According to industry insiders, classified management and encouragement of innovation are the two main lines of the draft, which have been reflected in the relevant policies previously issued, but the specific rules need to be improved.
Since 2013, CFDA has successively promulgated the "Medical Device Classification Rules" (Revised Draft), "Special Approval Procedures for Innovative Medical Devices (Trial)", "Medical Device Operation Quality Management Regulations (Draft for Comment)" and 104 medical device industries. Standards, the supervision of medical devices has achieved full coverage from registration, innovation review, production, circulation and operation.
