🇧🇩Bangladesh Medical Device Regulations

DGDA Quality Assurance Guideline for Medical Products (PDF)

DGDA guideline for quality assurance of locally sourced medical products. Defines marketing authorization requirements and quality standards.

DGDA Medical Devices Policy Document 2024 (PDF)

Official DGDA policy document for medical devices published January 2024. Contains classification requirements based on ASEAN guidelines (Class A-D).

Directorate General of Drug Administration - Medical Devices

DGDA under Ministry of Health and Family Welfare regulates medical devices in Bangladesh. Responsible for device registration, import licensing, and market surveillance.

Medical Device (Registration and Import) Rules 2019

Primary rules governing medical device registration and import in Bangladesh. Establishes classification, registration procedures, and import licensing requirements.

Medical Device Registration Requirements

Registration requirements for medical devices in Bangladesh. All devices require DGDA registration before import or manufacture.

Medical Device Import License Requirements

Import license requirements for foreign medical devices. Importers must hold valid import license and provide manufacturer authorization.

Medical Device Registration and Import Forms

Official application forms for medical device registration and import licensing. Includes registration forms, import permit applications, and supporting documents.

Drug (Control) Ordinance 1982 - Foundation Legislation

Foundation legislation establishing drug control framework in Bangladesh. Provides basis for medical device regulation under DGDA authority.