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Bangladesh - who.int

BangladeshWorld Bank income group: Lower middle incomeLegal Legal framework: Ye sAuthorizing legislation: N /AGuidelines: Guideline for Registration of Medical Devices for Manufacture & Import in Bangladesh ~dgdasite/littledms/ Registration Guidelines for Medical Devices Bangladesh [hereafter Guideline for Registration of Medical Devices] : The manufacture, import and sale of medical devices, which are regulated under the Drugs Act 1940 and Drug (Control) Ordinance 1982 & RulesNational Regulatory AuthorityNational Regulatory Authority present: Ye sName: Directorate General of Drug Administration of the NRA: N /AMedical device definitionMedical device defined: Ye sText: A device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, material or other similar or related article [.]

WHO South-East Asia Region Classes B, C, and D - certification by a notified body is required as to the design and manufacture of the service; manufacturers and importers must apply for permission along with supportive documents as to

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