800-810-1995

1.  ISO13485 standard: It is the medical equipment industry quality management standard made by International Standardization Organization (ISO). It was drafted by ISO/TC210 technical committee, and every member state has participated in the discussion and amendment. Chinese representatives also participated in the discussion. Both U.S.A. FDA (510K) and European CE abide by this standard, so they are different types of ISO13485.

2.  ISO13485: It is the global standardization certification to ensure the quality of medical equipment products from many aspects including product development and research, production and service, It is a certification compulsorily requirement for medical equipments in the world. Although there was lack of supervising and standardization work, standardization certification had been listed as one of the key jobs of State Food and Drug Administration.

3.  EN460001/46002 is the quality management standard in medical equipment trade promulgated by committee European normalization (CEN) and European electronics standardization committee. It is almost the same as ISO13485/13488. It was promulgated in 1996, and has been replaced by ISO13485.

4.  SDA is the style registration of the products leaving factory, and is the first step of medical products to enter the market, and its key points do not include the quality control of design, development, production and service. ISO13485: is the global standardization certification of the medical engineering products from the whole process of product development, production and service, etc.

5.  SDA adopts one time test for the sample product; ISO13485 quality control system is adopted, with on-site supervision and annual monitoring.

6.  SDA could ensure whether certain medical product can be sold or not. CMD (ISO13485) can ensure whether there is quality assurance of the products and company, and whether the production, service and development meet the requirements.

7.  The management department of SDA is the State Food and Drug Administration, while the management department of ISO13485 is CDM, under the leadership of State Food and Drug Administration, State Bureau of Technical Quality supervision, and the State Certification Centre.