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Provisions for Examining Medical Device Advertisements issued
2009/11/12 19:36:31
In order to enhance the medical device supervision, ensure the authenticity, legality and scientificity of medical device advertisements, Ministry of Health, State Administration of Industry and Commerce, and State Food and Drug Administration formally issued the revised Provisions for Examining Medical Device Advertisements and Criteria for Examining and Publishing Medical Device Advertisements recently. These regulations are base on Advertisement Law of the People’s Republic of China, Law of the People’s Republic of China against Unfair Competition, and Regulations for the Supervision and Administration of Medical Devices. The two revised provisions above mentioned would come into force on May 20, 2009.
There are 28 articles in the revised Provisions for Examining Medical Device Advertisements, which lay down the requirements of examining departments, approval procedure, approval time limits, applicant obligations, supervision and administration of medical devices, and other legal obligations.
The newly revised Criteria for Examining and Publishing Medical Device Advertisements contains 18 articles. Medical device advertisements are prohibited for products that are forbidden manufacturing, marketing, and using by food and drug regulatory departments. Furthermore, advertisements for medical devices may not contain the name or image of medical research unit, academic organization, medical unit or expert, doctor or patient as proofs.
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