This is to inform all stakeholders that the NMRA will implement a new process for filing applications related to new medical devices, effective from 05^thof August 2025.

Under this updated procedure, all new applications for registration of medical devices will be accepted as consolidated dossiers.

Applicants are advised to review the updated guideline (Guideline for consolidated dossier application submission and evaluation of medical device) and relevant checklist (Checklist for document accepting of consolidated medical device application) and ensure compliance with the new requirements when preparing submissions from the effective date onward.

Submission templates,checklists and guidance documents are available on the NMRA website.

For further information or clarifications, you may contact the MDRD/NMRA Division via the following email addresses:

·      pa6@nmra.gov.lk

·      aa16@nmra.gov.lk

·      aa20@nmra.gov.lk

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Chief Executive Officer/NMRA

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