To All Importers of Medical Devices

All importers of medical devices are hereby informed to submit following documents for the acceptance of new dossiers and re-registration dossiers of medical devices

Required documents for the new dossiers and re-registration dossiers of medical devices ‍

Comprehensive table of content (Index)

Application form signed by authorized person (schedule 1 Form A/Form B)

Letter of authorization from legal manufacturer

Copy of foreign manufacturing site approval letter (If applicable)

Copy of GMP report issued by NMRA for locally manufactured products

Copy of sample license (for New)/ previous registration (for RR)

Original free sale certificate issued by relevant health authority

Hygienic certificate (If applicable)

ISO certificate

EC certificate

EC design examination certificate (If applicable)

COA/Finished product inspection report

Stability report with protocol & declaration of shelf life (If applicable)

Sterility report (If applicable)

EO residual test report (If applicable)

Electrical safety data report (If applicable)

Performance evaluation test report for IVD (If applicable)

Biological evaluation report (If applicable)

Third party test report (If applicable)

Bovine Spongiform encephalopathy (BSE) report (If applicable)

Atomic energy authority approval for radiation emitting devices

List of countries with evidence for other country registration

List of standard accessories, spare parts, reagent & consumables (If applicable)

Instruction for use (IFU) for IVD kits

Product labels-Original/Artwork/ Draft & product catalogue

(Date: 30 June 2023)

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