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Medical Device Registration in Bangladesh
Government Authority (DGDA)
The Directorate General of Drug Administration (DGDA) in Bangladesh serves as the primary regulatory authority, ensuring the quality, safety, and efficacy of pharmaceuticals, medical devices, and health products in the country. Operating under the Ministry of Health and Family Welfare, the DGDA has jurisdiction over the import, production, distribution, and sale of drugs, medical devices, and cosmetics, ensuring compliance with established standards.
Bangladesh Medical Device Regulations
Bangladesh Drug and Cosmetics Act 2023, 18 September 2023 (Bengali)
Bangladesh Drug and Cosmetics Act 2023, 18 September 2023 (English)
Medical Device Status
Effective September 18, 2023, the Government of Bangladesh issued the Drug and Cosmetics Act, 2023 formalizing the requirements for medical devices, IVD reagents and adding software to the definition of medical devices, which falls under Drugs in the regulations.
Definition of Medical device in the Drugs and Cosmetics Act, 2023:
“medical device” includes-
(a) all devices including an instrument, apparatus, implement, machine, appliance, implant, diagnostic reagent (in vitro, in vivo and in silico reagent), software or similar/related material or other article, whether used alone or in combination, to be used specially for human beings or animals by such means for one or more of the specific purposes of:
(i) diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) control of conception or disinfection of medical devices;
(vi) To provide information through examination and analysis of samples collected from human or animal body whose desired action is not affected by pharmacological, immunological, and metabolic action.
(b) Any device and diagnostic reagent declared by the Government, by notification in the Official Gazette, for the purpose of carrying out the purposes of this Act.
Product Classification and Grouping
Medical devices are classified into 4 categories; A, B, C, and D based on risk level and closely aligns to the ASEAN MDD. Product codes included in a License are based on the leveraged CFS and therefore, grouping often follows the product codes listed on the CFS but can become complicated depending on their classification and how they’re sold.
Medical Device Registration Process
Applications for Marketing Authorization Certificates for Class B, C, and D devices follow a 2-step process. The first step is a primary review to confirm applications contain all the required elements and occurs once per quarter. Once an application has passed the primary review, a ‘Recipe Approval’ letter is issued, and the application then enters the Final registration process where all documents are fully reviewed.
European CE Marking is not required but a Certificate of Free Sale (CFS) and ISO 13485 from a Reference Country (EU, USA, Canada, Japan, Australia) is required for Class C and D products. Class A and B only require a CFS from the country of origin. Manufacturers must obtain attestations from the Bangladesh embassy for their CFS and ISO 13485 certificate and provide both original copies to their local license holder to be submitted as part of the application.
|Application Preparation*||DGDA Timelines|
|New Registration||10 Days||4 – 6 months|
|Renewal||10 Days||2 – 3 months|
|Change Amendment||10 Days||1 month|
Once issued Marketing Authorization Certificates, Class B, C, and D Licenses are valid for 5 years and can be renewed in about 2 to 3 months with a fee of ~USD120. Class A Certificates do not expire.
Quality Systems Conformity Assessment
Class B, C, and D devices all require ISO 13485 certificates to certify the quality system/s of the legal and/or actual manufacturing facilities.
License Holder Requirements
Import Licenses are issued to a local, licensed company that will own and represent the manufacturer. Multiple license holders for the same device at the same time are not permitted. 3rd party license holders, like Asia Actual, can be appointed by foreign manufacturers who can then authorize multiple distributors/importers.
The License Holder does not need to be a part of the importing process unless needed. Manufacturers are able to work directly with their distributor(s) for importation. However, the license holder (Asia Actual) will need to issue a No Objection Certificate (NOC) for each importation.
Australia – Canada – European Union – Japan – United States
Maximum Retail Price (MRP) & Labeling Requirements
In Bangladesh, it is mandatory for all medical devices to have a Maximum Retail Price (MRP) affixed to their local labeling. Asia Actual offers support for this process if needed; however, Importers and Distributors are also capable of completing this requirement independently.
Local labeling is required after importation (i.e., after customs clearance) and will need to reflect the following:
- Name of the Importer
- Expiry Date
- Batch no./Lot no.
- MRP: in Bangladeshi Taka (BDT)
Manufacturers are able to transfer licenses, but the original registration certificate is required to complete the transfer process. Original registration certificates are typically held by the license holder and without their support, license transfers are not possible and a new registration will be required. There is no processing fee for transferring a license.
Benefits of Using Asia Actual as Your Independent License Holder
- Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
- Monitor transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
- Easy, expedited registrations for distributors
- Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual for assistance with your medical device registration in Bangladesh or to confirm the cost and timelines that apply to your specific devices of interest. Asia Actual has experienced, bi-lingual consultants in Bangladesh to help you manage the application, importing, and post-market surveillance needs.
Bangladesh Regulatory Support
Bangladesh Sales Support
Bryan’s Regulatory Hint
“With the new regulations implemented, manufacturers must now comply with local regulations to maintain market access in Bangladesh and avoid potential penalties.”
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Latest Market Updates
Frequently Asked Questions – Bangladesh Medical Device Registration Requirements
Do I need to register my medical device in Bangladesh?
Yes, per the Bangladesh Drug and Cosmetics Act 2023, released 18 September 2023, all medical devices (including software) must work with a local company to register their products with the DGDA.
Who can submit submit applications in Bangladesh?
A local entity must submit applications, hold the license, and correspond with the Directorate General of Drug Administration (DGDA). License Holders do not need to be part of the importing process.
How are products classified in Bangladesh?
Medical device classification closely follows the ASEAN MDD classification guidelines, with Class A, B, C and D designations ranked from low to high risk categorization.
How long does it take to register my medical device in Bangladesh?
New registrations typically require 4 to 6 months to be reviewed and approved. Contact us for the latest timelines.
How much does it cost to register my device in Bangladesh?
As of October 2023, the total fees for a new registration in Bangladesh are about US$600 and US$120 for amendments.
How long are medical device licenses valid in Bangladesh?
Class B, C, and D Licenses are valid for 5 years and can be renewed in about 2 to 3 months with a fee of ~USD120. Class A Licenses do not expire.
Does the license holder need to be a part of the importing process?
No, license holders do not need to be part of the importing process as of October 2023.
Is there an expedited review pathway in Bangladesh?
No, there is not an expedited review but manufacturers must have Reference Country approval for Class C and D medical devices while only a CFS from the country of origin is required for Class A and B.
Is ISO 13485 required for medical devices in Bangladesh?
Yes, ISO 13485 is required to register all classes of devices.
Is Home Country approval required?
No, there are no requirements for home country approval but Reference Country approval is required for Class C and D products while home country approval (with a CFS) is sufficient for Class A and B registrations.
Do documents need to be translated as part of the application process?
No, application documents can be submitted in English.