Starting from September 18, 2023, the Drug and Cosmetics Act, 2023, introduced by the Government of Bangladesh, has officially outlined the stipulations for medical devices and in vitro diagnostic (IVD) reagents. Notably, the definition of medical devices has been expanded to include software, which is now categorized under Drugs in the regulations.
The Directorate General of Drug Administration (DGDA) is responsible for ensuring the quality, safety, efficacy, and safety of pharmaceutical products through the implementation of relevant legislation. Its responsibilities include ensuring the availability and affordability of essential drugs, evaluating new projects, issuing, and renewing drug manufacturing licenses, and registering and renewing drug products.
They also fix and certification prices for drug products, inspect pharmaceutical establishments, approve block lists for import of raw and packaging materials, and indent for import of finished drugs.
Surveillance and pharmacovigilance activities are also carried out.
The DGDA also prosecutes cases in drug courts and other courts, and issues export licenses, FSC (Free Sales Certificate), GMP (Good Manufacturing Practices) Certificate, and CPP (Certificate for Pharmaceutical Products).The organization aims to meet the needs of the people by ensuring the safety, efficacy, and quality of medicines.
Drugs Act, 1940
Class | Risk-Level | Example |
Class A | Low | Surgical retractors / tongue depressors |
Class B | Low-Moderate | Hypodermic Needles / suction equipment |
Class C | Moderate- High | Lung ventilator / bone fixation plate |
Class D | High | Heart valves / implantable defibrillator |
As of October 2023, the total fees for a first-time registration in Bangladesh amount to approximately US$600. For amendments to existing registrations, the fees stand at US$120.
Class A Licenses do not expire, Licenses of Class B, C, and D are initially valid for a period of 5 years. Renewal of these licenses can be processed within approximately 2 to 3 months, and a renewal fee of approximately USD 120 is applicable.
Before placing a medical device into the market.
Contact us for free consultation: info@omcmedical.co.uk
https://www.worldexindia.com/medhealthexpos/bdmhve/assets/pdf/medica-device-guideline-annexure.pdf
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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