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The State Drug Administration announced that 119 medical device policy documents were invalid and abolished.
Date:2018-10-09 Publisher:Ebay Medical

On September 27, the official website of the State Drug Administration issued a bulletin announcing the results of cleaning up the standardized documents on medical devices (1998-2013). 99 policy documents were abolished and 20 declared invalid. At the same time, 114 valid documents remain.


According to the announcement, the State Drug Administration organized a clean-up of the 1998-2013 normative documents on medical devices and decided to repeal and declare them invalid in order to do a good job in the legal system of drug supervision "reform and abolition" and comprehensively promote administration according to law in accordance with the requirements of the "Outline for the Construction and Implementation of a Government under the Rule of Law (2015-2020)". A number of normative documents.


The above-mentioned normative documents, which have been annulled or declared invalid, do not involve the validity of past disposal decisions made on the basis of these documents, unless otherwise specified.


From the abolished documents, the industry's supply and marketing links will usher in new norms. For example, the abolition of the Notice on the Issue of Flight Inspection Procedures (Trial) for Medical Device Manufacturers implies that there will be new rules for Flight Inspection Procedures; and the abolition of the Notice on the Implementation of the Standards for the Quality Control of Medical Device Production (Trial) and its supporting documents will fully implement the new GMP for Medical Devices. After the abolition of the Notice on Further Standardizing the Suspension of Testing of Medical Devices Abroad, new norms will come.


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