엠디웍스코리아

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Licensing

Import Manufacturing License

Initial business license

Initial business license

Import
  • Medical Devices Act Article 15; Enforcement Rules of the same Act Articles 29 and 34
  • In Vitro Diagnostic Medical Devices Act Articles 5 and 11; Enforcement Rules of the same Act Articles 4 and 25
  • Digital Medical Products Act Articles 8 and 12; Enforcement Rules of the same Act Article 5(1) and Article 20
Manufacturing
  • Medical Devices Act Article 6; Enforcement Rules of the same Act Article 3
  • In Vitro Diagnostic Medical Devices Act Articles 5 and 11; Enforcement Rules of the same Act Articles 4 and 25
  • Digital Medical Products Act Articles 8 and 12; Enforcement Rules of the same Act Article 5(1) and Article 20

Requirements for obtaining a business license

Common documents (individual and corporate)
  • Medical device import/manufacturing license application
  • In vitro diagnostic medical device import/manufacturing license application
  • Digital medical device import/manufacturing license application
  • Designation of quality assurance manager
  • One or more concurrent import/manufacturing notifications, certifications, or approvals
Additional documents
Individual business
Representative’s medical examination certificate
Corporate business
Corporate register extract

Business license change

Legal basis

Import
  • Medical Devices Act Article 12; Enforcement Rules of the same Act Article 26(1) and Article 34
  • In Vitro Diagnostic Medical Devices Act Articles 10 and 11; Enforcement Rules of the same Act Articles 24 and 28
  • Digital Medical Products Act Article 11; Enforcement Rules of the same Act Article 19(3)
Manufacturing
  • Medical Devices Act Article 12; Enforcement Rules of the same Act Article 26(1) and Article 34
  • In Vitro Diagnostic Medical Devices Act Articles 10 and 11; Enforcement Rules of the same Act Articles 24 and 28
  • Digital Medical Products Act Article 11; Enforcement Rules of the same Act Article 19(3)

When a business license change is required

  • Change of business name

  • Change of address

  • Change of representative

  • Change due to transfer of business

  • Change of quality assurance manager