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 From for Sample Import License - Medical Devices

Chief Executive Officer

NMRA

(Date : 04 January 2023)

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