Announcement on Printing and Distributing the National Standard for Equipment and Equipment for Medical Device Testing Institutions (2011-2015)
National Food and Drug Administration [2012] No. 63
Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:
In order to strengthen the inspection capacity building of medical device testing institutions, standardize the equipment and equipment of medical device testing institutions, and improve the level of supervision of medical devices, the State Bureau has formulated the National Standard for Equipment and Equipment for Medical Device Testing Institutions (2011-2015), which is now issued to You and notify the relevant matters as follows:
1. This standard is based on the National Instrumentation and Equipment Standards (Trial) (2005-2010) of the National Medical Device Testing Institution. It is based on national standards and industry standards for medical devices and references some international standards. Taking into account its forward-looking nature to protect the needs for the development of medical device supervision during the “12th Five-Year Plan†period, it is necessary equipment for carrying out medical device registration inspection, supervision and random inspection, emergency protection and safety evaluation.
2. The food and drug regulatory agencies of provinces, autonomous regions, and municipalities directly under the Central Government shall, in conjunction with the actual situation of the National Drug Safety "Twelfth Five-Year Plan", the special planning of the area under their jurisdiction, and the supervision of medical devices, co-ordinate arrangements, focus, and speed up equipment to meet medical conditions. The need for device supervision. The medical device testing institution shall select and equip the related inspection equipment and equipment according to this standard in accordance with the inspection tasks undertaken, the capabilities of the existing inspection equipment and the development direction of the inspection technology.
National Food and Drug Administration [2012] No. 63
Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:
In order to strengthen the inspection capacity building of medical device testing institutions, standardize the equipment and equipment of medical device testing institutions, and improve the level of supervision of medical devices, the State Bureau has formulated the National Standard for Equipment and Equipment for Medical Device Testing Institutions (2011-2015), which is now issued to You and notify the relevant matters as follows:
1. This standard is based on the National Instrumentation and Equipment Standards (Trial) (2005-2010) of the National Medical Device Testing Institution. It is based on national standards and industry standards for medical devices and references some international standards. Taking into account its forward-looking nature to protect the needs for the development of medical device supervision during the “12th Five-Year Plan†period, it is necessary equipment for carrying out medical device registration inspection, supervision and random inspection, emergency protection and safety evaluation.
2. The food and drug regulatory agencies of provinces, autonomous regions, and municipalities directly under the Central Government shall, in conjunction with the actual situation of the National Drug Safety "Twelfth Five-Year Plan", the special planning of the area under their jurisdiction, and the supervision of medical devices, co-ordinate arrangements, focus, and speed up equipment to meet medical conditions. The need for device supervision. The medical device testing institution shall select and equip the related inspection equipment and equipment according to this standard in accordance with the inspection tasks undertaken, the capabilities of the existing inspection equipment and the development direction of the inspection technology.
Rushan Jinguo Food Co., Ltd , https://www.jinguofood.cn