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Bangladesh Launches New Medical Device Regulations
Published on: October 17th, 2023
On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect. A translated version of the document is available on Asia Actual’s website here. All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.
Significance of the New Medical Device Regulations
Previously, the DGDA published guidance for the registration of medical devices under the Drugs Act, 1940 and Drugs (Control) Ordinance, 1982.). However, enforcement was not deemed implementable. The new Act provides a legal framework for enforcement of the regulatory guidelines and procedures already in place and includes prescribed fines and imprisonment times for specific transgressions.
The new Act further includes the refined definition of a medical device which now specifically includes software (SaMD) and veterinary devices.
Medical Device Registration Procedure in Bangladesh
The registration process for medical and IVD devices is relatively simple, but does requires reference country (EU, USA, Canada, Japan, Australia) approval for risk class B, C and D devices. Then just a few administrative documents such as the Certificate of Free Sale (CFS) and ISO 13485 are required. The government processing fee is approximately US$600 and will take 4 to 6 months.
- Risk based classification system (A, B, C and D) for medical and IVD devices
- Application processing fees charged by the government will be US$600
- Market Authorization Certificates are valid for 5 years
- Local labeling requirements can be met after Customs clearance
- Registration certificates are issued to a local license holder which may appoint commercial partners to import directly
Foreign manufacturers are advised to evaluate how the new regulations apply to their product portfolio and consider early preparation of new registration applications.
Please contact Asia Actual with any question or support requests for product registration and independent license holding in Bangladesh.
For more information on the regulatory requirements in Bangladesh for medical devices, please see our dedicated page on the topic here.
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Please contact us if you’d like support from our experienced staff registering your device in India. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.