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MALAYSIA: MDA Updates the Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) – November/December 2022

MALAYSIA: MDA Updates the Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) – November/December 2022

  • 2022-11-29 02:42:41

The Medical Device Authority (MDA) updates the guideline for Licensing for Establishments. The establishment must comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices. The Medical Device Authority (MDA) created this guidance document to assist the healthcare sector and the industry in their efforts to comply to the Medical Device Act's (Act 737) laws and requirements.

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SINGAPORE: Updates Introduced to Pre-Market Registration Guidance Documents – September, 2021

SINGAPORE: Updates Introduced to Pre-Market Registration Guidance Documents – September, 2021

  • 2021-09-29 00:33:56

HSA recently issued updates to some pre-market registration-related guidance documents and technical reference documents. Specifically, the GN-15, GN-17, GN-18, TR-01, and TR-02 were updated. The changes mainly deal with the addition of cybersecurity requirements for medical devices. This is a very important update since it is imperative to protect devices that are used in the healthcare industry from hackers and other cyberthreats.

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 PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

  • 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

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