{"id":2020,"date":"2025-11-24T12:17:33","date_gmt":"2025-11-24T05:17:33","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&p=2020"},"modified":"2025-11-28T18:23:07","modified_gmt":"2025-11-28T11:23:07","slug":"trung-quoc","status":"publish","type":"dich_vu","link":"http:\/\/mednovum.com.vn\/en\/dich-vu\/china\/","title":{"rendered":"China"},"content":{"rendered":"

CHINA<\/h2>\n\t
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Entering the Chinese market presents immense opportunities for medical device manufacturers due to its vast scale and growing healthcare demands. However, achieving successful market access requires navigating a highly complex and dynamic regulatory landscape.<\/p>\n

The National Medical Products Administration (NMPA or national MPA) serves as the ultimate competent authority, enforcing a stringent and comprehensive regulatory framework to ensure product safety, efficacy, and quality. A cornerstone of this framework is the mandatory appointment of an In-Country Representative, a locally established entity that bears legal responsibility for product registration, post-market surveillance, and compliance.<\/p>\n

Consequently, partnering with a deeply experienced local regulatory expert is not merely an advantage but an essential prerequisite for navigating the NMPA's distinct requirements and achieving a successful market entry.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>

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Definition of medical devices<\/h2>\n\t
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Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software; their utility is mainly obtained through physical methods, etc. It is not obtained through pharmacology, immunology, or metabolism, or although these methods are involved but only play a supporting role; its purpose is:<\/p>\n

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  • Diagnosis, prevention, monitoring, treatment, or alleviation of diseases,<\/li>\n
  • Diagnosis, monitoring, treatment, mitigation, or functional compensation of injury,<\/li>\n
  • Inspection, substitution, adjustment or support of physiological structure or physiological process,<\/li>\n
  • Life support or maintenance,<\/li>\n
  • Pregnancy control,<\/li>\n
  • Provide information for medical or diagnostic purposes by examining samples from the human body.<\/li>\n<\/ul>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>
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    Classification<\/h2><\/div><\/div><\/div>
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    • Class I devices<\/strong> \u2013<\/strong> Low risk<\/strong>: Medical devices that implements routine management which can ensure their safety and effectiveness.<\/li>\n
    • Class II medical device<\/strong> \u2013 Moderate risk: <\/strong>Medical devices that requires strict control and management to ensure their safety and effectiveness.<\/li>\n
    • Class III devices<\/strong> \u2013 High risk<\/strong>: Medical devices that requires special measures to strictly control and manage them to ensure their safety and effectiveness.<\/li>\n<\/ul>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>

      Competent Authorities and Registration Process<\/h2>\n\t
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      Type of medical device<\/strong><\/td>\nThe Registration Pathway<\/strong><\/td>\nRegulatory Authority<\/strong><\/td>\n<\/tr>\n
      Class I devices<\/td>\nDomestic medical devices<\/td>\nFiling documents<\/td>\nMunicipal MPA<\/td>\n<\/tr>\n
      Import medical devices<\/td>\nNMPA<\/td>\n<\/tr>\n
      Class II medical device<\/td>\nDomestic medical devices<\/td>\nRegistration<\/td>\nProvincial MPA<\/td>\n<\/tr>\n
      Import medical devices<\/td>\nNMPA<\/td>\n<\/tr>\n
      Class III devices<\/td>\nRegistration<\/td>\nNMPA<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>

      Options for registration applicant<\/h2>\n\t
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      Our Services<\/h2>\n