Application for Medical Device Product Certification Certificate

If a general medical device is only produced and sold in China, only a business license, production license (excluding Class I products), and product registration certificate are required. During the process of applying for product registration, the drug regulatory agency will conduct quality management system assessments or review the production implementation rules of the enterprise, and issue assessment reports. Other certifications (such as CE, FDA, ISO13485) are voluntary, but if the product is listed in the national CCC mandatory certification directory, It must pass CCC certification

The name of the product subcategory is based on the corresponding international standard number. Implementation Rule No. 1701 Electrocardiogram GB10793-2000IEC 60601-2-25:1993CNCA-08C-032 2001 "Implementation Rules for Compulsory Certification of Medical Device Products" (Electrocardiogram) GB9706.1-1995IEC 601-1:19881702 Hemodialysis Machine GB9706.1-1995IEC 601-1:1988CNCA-08C-033 2001 "Implementation Rules for Compulsory Certification of Medical Device Products" (Hemodialysis Devices) GB9706.2-2003 IEC 60601-2-16:1998, 1703 Extracorporeal circulation pipeline for blood purification equipment YY0267-1995; CNCA-08C-034 2001 "Implementation Rules for Compulsory Certification of Medical Device Products" (Extracorporeal Circulation Pipeline for Blood Purification Devices) 1704 Hollow Fiber Dialyzer YY0053-1991; CNCA-08C-035 2001 "Implementation Rules for Compulsory Certification of Medical Device Products" (Hollow Fiber Dialyzer) 1705 Implantable Heart Pacemaker GB16174.1-1996 ISO 5841-1:1989 CNCA-08C-036 2001 "Implementation Rules for Compulsory Certification of Medical Device Products" (Implantable Heart Pacemaker) 1706 Medical X-ray Diagnostic Equipment GB9706.1-1995 IEC 601-1:1988 CNCA-08C-037 2001 "Implementation Rules for Compulsory Certification of Medical Device Products" (Medical X-ray diagnostic equipment) GB9706.11-1997IEC 601-2-28:1993GB9706.12-1997IEC 601-1-3:1994GB9706.14-1997IEC 601-2-32:1994GB9706.15-1999IEC 60601-1-1:1995GB9706.18-2006IEC 60601-2-44:2002GB9706.3-2000IEC 60601-2-7:19981707 Artificial Heart and Lung Machine Rolling Blood Pump GB12260-2005  CNCA-08C-038 2001 "Implementation Rules for Compulsory Certification of Electrical and Electronic Products" (Rolling Blood Pump for Artificial Heart and Lung Machines) GB9706.1-1995 IEC 601-1:19881708 Rolling Pulse Blood Pump for Artificial Heart and Lung Machines GB12260-2005  CNCA-08C-039 2001 "Implementation Rules for Compulsory Certification of Electrical and Electronic Products" (Artificial Heart and Lung Machine Rolling Pulse Blood Pump) GB9706.1-1995 IEC 601-1:19881709 Artificial Heart and Lung Machine Bubble Oxygenator YY0604-2007 ISO 7199:1996, MODCNCA-08C-040 2001 "Implementation Rules for Compulsory Certification of Electrical and Electronic Products" (Artificial Heart and Lung Machine Bubble Oxygenator) 1710 Artificial Heart and Lung Machine Heat Exchanger YY0604-2007 ISO 7199:1996, MODCNCA-08C-041 2001 "Implementation Rules for Compulsory Certification of Electrical and Electronic Products" (Artificial Heart and Lung Machine Heat Exchanger) 1711 Artificial Heart and Lung Machine Heat Exchange Water Tank GB12263-2005; CNCA-08C-042 2001 "Implementation Rules for Compulsory Certification of Electrical and Electronic Products" (Artificial Heart and Lung Machine Heat Exchange Water Tank) GB9706.1-1995 IEC 601 1:19881712 Artificial Heart and Lung Machine Silicone Rubber Pump Tube YY91048-1999; CNCA-08C-043 2001 "Implementation Rules for Compulsory Certification of Electrical and Electronic Products" (Silicone Rubber Pump Tube for Artificial Heart and Lung Machines)