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      Global Test Service
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      medical instruments

      2018-05-14 15:57:47 The number of clicks:

      Medical devices are directly related to people's lives and health. Countries in the world have formulated more stringent laws and regulations for medical device products than other products. Medical devices with high standards and safety are better served by people. As a third-party testing institution authorized by CNAS for specialized medical devices, it has established good cooperation with many international public notice agencies such as DNV, TUV, MED/CERT, UL, NQA, and AP, and can conduct professional testing for medical device products entering European and international markets. Consultation, Certification Services Medical Device Directive (MDD 93/42 EEC), MDD Directive applies to most medical devices sold into the European Union. It is divided into 6 categories according to different requirements for assessment by certification bodies.


                                                                                                                                                                                                                                                                                                                                      

                           Level                 

                  
                      

                           Design stage                 

                  
                      

                           Production stage                 

                  
                      

                           I class                 

                  
                      

                           Self-Compliance Statement                 

                  
                      

                           Self-Compliance Statement                 

                  
                      

                           I type (measurement function)                 

                  
                      

                           Self-Compliance Statement                 

                  
                      

                           Notification Agency                 

                  

                           Class I (Sterilization)                 

                  
                      

                           Self-Compliance Statement                 

                  
                      

                           Notification Agency                 

                  
                      

                           Class IIa                 

                  
                      

                           Self-Compliance Statement                 

                  
                      

                           Notification Agency                 

                  
                      

                           Class IIb                 

                  
                      

                           Notification Agency                 

                  
                      

                           Notification Agency                 

                  
                      

                           Class III                 

                  
                      

                          Notice Agency                 

                  
                      

                           Notification Agency                 

                  

          

          The directive issued by the European Community on medical device products needs to be fulfilled as follows:

          

          

                                                                                                                                                                                                                                                                                                  
                          

                                Name                     

                      
                          

                                CE Ref. directive                     

                      
                          

                              
                          

                          

                               Product examples                     

                      
                          

                                 Implantable Medical Devices Directive                     

                          

      (medical device implanted in human body)                     

                      
                          

                                90/385/EEC                     

                      
                          

                                Pacemakers                     

                      
                          

                                Ordinary Medical Device Directive                     

                      
                          

                                93/42/EEC                     

                      
                          

                                monitors, electric wheelchairs, electrocardiography, ultrasound                     

                      
                          

                                In vitro diagnostic medical device directive                     

                          

                               (Laboratory equipment that takes human secretions for testing and diagnosis)                     

                      
                          

                                98/79/EC                     

                      
                          

                                Urinalysis analyzer microplate reader, blood glucose meter


       

       

      2. In Vitro Diagnostic Directive IVDD98/79 CE Certification: With the passage of the European IVD Medical Device Directive (IVDD&nbsp98/79/EC), the requirements of the IVD Medical Device Directive are mandatory for all EU Member States.
      3. International Standard ISO 13485 is an independent, quality management system standard for the medical device industry. It allows you to react flexibly to market and international competition. As a third-party testing and certification organization, Global Connect Testing integrates with international certification agencies and domestic consulting companies to provide you with the support you need. This international standard specifies the design/development, production, customer service and assembly quality assurance system for medical devices. It includes all GMP principles applied to the production of medical devices (GMP = Good Manufacturing Practice). Based on ISO 9001 requirements, ISO&nbsp13485 must also meet a series of additional standards.
      4. FDA510(K) : Premarket Notification 510(K) is the most common method of approval for medical products or IVD products in the United States. As a third-party testing agency, Global Pass Testing can perform 510 (k) consulting, testing and certification services for most Type II devices.
      5. US FDA Profile: The US Food and Drug Administration (FDA) is affiliated with the U.S. State Department’s Department of Health and Human Services (U.S.  Department Of Health and Human Services)

      6. Domestic SFDA: All medical devices sold and used in China shall be in accordance with the SFDA's "Administrative Measures for Registration of Medical Device Products" For registration, medical devices that have not been approved for registration may not be sold or used.

          Furthermore, the following 7 categories of medical device products must also be registered with the Food and Drug Administration's medical device registration and CCC certification:

      ?  Medical X-ray diagnostic equipment
      ? hemodialysis devices

      ? hollow fiber dialyzer
      ?  Circulation tube
      ? Electrocardiograph

      ? Implantable cardiac pacemaker
      ? artificial heart-lung machine


      Common Products

      ※In Vitro Diagnostic Devices (IVD)

      ※Ordinary Medical Devices (MDD)<br 〈
      ※Medical X-ray Diagnostic Equipment

      ※Hemodialysis Equipment

      ※Hollow-fiber Dialyzer
      ※ Blood Purification Equipment Extracorporeal circulation tub
      ※Electrocardiograph
      ※ Implantable cardiac pacemaker

      ※Artificial heart-lung machine     

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