All importers of Medical Devices are hereby informed to submit Application and additional details for Sample Import License of Medical Devices to Dossier Accepting Point, Medical Devices only on Tuesdays at NMRA Norris Canal Road Office with effective from 01st of January 2023.
Required documents for the Sample Import License Application
- Application form for Each product (Form C Schedule IV)
Business Registration Certificate
Letter of authorization
Free Sale Certificate
ISO 13485 Quality management system certificate ( not mandatory for NMRA approved site)
Declaration from the manufacturer regarding the confirmation of type and class of the medical device
Existing Registration Certificate issued by NMRA/FMSA approval by the NMRA
Product Catalogue/ Brochure
Sri Lanka Atomic Energy Authority approval for Radiation Emitting Device
Acknowledgement Form for Sample Import License –Medical Devices
Chief Executive Officer
NMRA