Newsletter

INDONESIA: Digital signature implementation - December, 2018

INDONESIA: Digital signature implementation - December, 2018

  • 2020-02-12 14:03:26

Starting January 2019, Medical Device Marketing Authorization License will be issued in electronic form. This is in accordance to PMK No. 62 year of 2017 Article 22, which stated that Marketing Authorization License will not require stamp and wet signature anymore.

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HONG KONG: In Vitro Diagnostic Medical Device Classification Program - November 2018

HONG KONG: In Vitro Diagnostic Medical Device Classification Program - November 2018

  • 2020-02-12 14:12:33

MDCO has created and developed a Web-based In Vitro Diagnostic Medical Device Classification Program, where previously only the classification program for General Medical Device was available. This is to facilitate the classification of the In Vitro Diagnostic Medical Device according to its risk level under the Medical Device Administrative Control System.

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