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Medical Device Product Registration and Approval in Bangladesh

MEDICAL DEVICE REGULATION IN BANGLADESH

Medical devices are regulated by the Directorate General of Drug Administration (DGDA) from the Ministry of Health & Family Welfare whose objective is to ensure that the common people have easy access to useful, effective, safe and good quality medical device at an affordable price. Medical devices are regulated under the Drugs Act.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN BANGLADESH

Medical devices are classified into 4 categories namely class A, B, C and D (A being the lowest risk and D being the highest risk).

The registration requirements are based on the Global Harmonization Task Force (GHTF) documents.

RESOURCES:

Regulations:

• http://www.dgda.gov.bd/index.php/laws-and-policies

Guidance Documents:

• http://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/guidance-documents

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SAMPLE FOR BANGLADESH CERTIFICATION OF REGISTRATION

Source: DGDA