To the product manufacturer where the municipal Drug Administration inspection brigade complaints and provide appropriate evidence Your business location Drug Administration (district and county level or municipal level can be) can also be to the other side of the location of the municipal Drug Administration inspection brigade to send a letter to the request for co-inspection.
Expanded Information:
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration), the relevant units:
In order to strengthen the supervision and management of medical devices, to ensure the safety of public use of equipment, according to the "Medical Devices Instruction Manual, Labeling and Packaging Labeling Regulations" (State Food and Drug Administration Decree No. 10, hereinafter referred to as the "Administrative Provisions"), the standardization of overseas Medical device labeling and packaging identification of the relevant matters are notified as follows:
I, in the Chinese people *** and the State sales, use of medical devices should be in accordance with the "Management Regulations" with labeling and packaging identification. Labeling and packaging identification of text content must be used in Chinese, can be attached to other languages. Not in accordance with the provisions of the Chinese labeling and packaging identification of foreign medical devices, shall not be sold and used.
Two, overseas medical device manufacturers should be established in the quality management system to ensure that its sales in China, the use of medical devices in line with the "Management Regulations" control procedures, the formation of documents, and effective implementation to ensure that its sales in China, the use of medical devices are safe and effective.
Third, the meaning of the terms and terminology involved in this notice is the same as the meaning of the relevant terms and terminology in the Administrative Provisions and Measures for the Administration of Registration of Medical Devices (State Food and Drug Administration Decree No. 16). This notice from April 1, 2013 shall come into force.