Medical device registration in Bangladesh
M Saiful Islam
CEO at Ziva DRA || Regulatory Affairs Consultant (Medical device, IVD, Cosmetics & API) || Regulatory & Compliance service provider in Bangladesh
Medical device market size in Bangladesh:
According to the Bangladesh Investment Development Authority (BIDA), the medical device market is currently valued at $442 million and is expanding at a rate of 13% per year.
The yearly demand for medical devices is estimated to be Tk 200 billion by the Bangladesh Association for Medical Devices & Surgical Instruments Manufacturer and Exporter (BAMDSIME), and it has been expanding at a rate of about 20 percent over the past several years.
Approximately ten companies produce medical equipment and accessories: Getwell, JMI, Techno Drugs, Incepta Pharmaceuticals, Bi-beat, Promixco, and Opso Saline.
In the 1990s, Opso Saline launched local manufacture, which was later joined by JMI and other companies.
Medical device law in Bangladesh:
The Drug and Cosmetics Act, 2023, published by the Bangladeshi government, went into effect on September 18, 2023. It formalized standards for IVD reagents, medical devices, and included software to the definition of medical devices, which is categorized under drugs in the rules.
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:
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(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.
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Medical device classifications in Bangladesh:
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Medical devices are closely aligned with the ASEAN MDD and are categorized into four groups, A, B, C, and D, based on their level of risk.
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Import base Medical device registration required documents:
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Mentioned documents are required for first-time registration only. Each registration validity 5 years. After 5 years, local distributors need to renewal again.
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Required documents for Import base Medical device registration RENEWAL:
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Class A medical device declaration/registration:
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The government fee for registering medical devices in Bangladesh:
Ziva DRA is your regulatory consultant for Medical device registration in Bangladesh:
For the registration and compliance of medical devices in Bangladesh, Ziva DRA provides crucial services that have several advantages for producers and distributors.
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In summary, Ziva DRA’s comprehensive services ensure efficient, compliant, and successful medical device registration in Bangladesh, facilitating smoother and more effective market entry.
Contact us at [email protected] or [email protected]
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