Singapore: Medical Device Regulatory Updates


Medical Device Pre-market Registration

A submission guide that maps the various modules in our MEDICS system to the ASEAN CSDT dossier and to the IMDRF ToC has been developed to assist applicants with their online submission.

Upcoming:

Online Reporting System for Recalls and Field Safety Corrective Actions

  • Expected to be launched in Q4 2019)

Guidance on Requirements for Registration of Next Generation Sequencing IVD medical devices (NGS IVDs)

  • Document has been published for consultation on website

  • Consultation period ends 31 August 2019

  • https://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Regulatory_Updates/Requirements%20for%20NGS%20IVDs%20(for%20consultation).pdf

Guidance on the regulatory requirements for medical device software – a lifecycle approach

  • In development

Reference: Medical Devices Branch, Health Sciences Authority Singapore

Contact us at info@arqon.com.


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