Singapore: HSA preparing manufacturer for the new ER IMDRF elements and cybersecurity.
The new version Essential Requirements (ER) checklist incorporate elements such as cybersecurity and detailed clarifications including risk management plan, clinical evaluation sources etc.
At present, the earlier version of the Singapore Essential Principles conformity checklist (Dec 2017 version) will continue to be accepted for purposes of registration in Singapore. Registrants may choose to submit either version of the Singapore Essential Principles conformity checklist (i.e. Annex 2 or Annex 3) for device registration in Singapore. Essential Principles conformity checklists prepared for approvals or clearance from HSA reference regulatory agency jurisdictions will also continue to be accepted for device registration in Singapore.
The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory harmonization. It consists of a group of medical device regulators from around the world* to accelerate international medical device regulatory harmonisation and convergence. The Health Sciences Authority (HSA) is a management committee member since 2016. As a member, HSA participates actively on all expert working groups and votes on matters raised at the IMDRF meetings.
These changes in ER was identified by ARQon product development consultancy team while helping manufacturer in compliance to local and global requirements in product design, development, manufacturing, and labelling.
Contact us at info@arqon.com.