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市场信息
Bangladesh’s healthcare expenditure was Taka 777 billion in 2020, making up 2.8% of the GDP (BNHA 1997-2020). Concurrently, government health expenditure in the same year amounted to Taka 179.74 billion, constituting 23% of THE (equivalent to 0.66% of GDP).
Market Trend: Health insurance usage is relatively new in Bangladesh. On average, Bangladeshi citizens must pay 63.3% of the total cost, while the government pays the rest.
Bangladesh’s medical equipment market has a present market valuation of USD 442 million and showcases a Compound Annual Growth Rate (CAGR) of 13%, the medical equipment and devices sector is anticipated to reach USD 820 million by the year 2025.
The Directorate General of Drug Administration was founded in 1976 as an independent department under the Ministry of Health and Family Welfare. It underwent an elevation on 17 January 2010. This department holds the responsibility of granting licenses to pharmaceutical companies. The Drug Control Committee within this department makes decisions concerning drug registration.
Medical Device Regulation
Directorate General of Drug Administration (DGDA), under the MOHFW.
分类、费用、时间表
DEVICE CLASS | FEES | TIMELINE |
|---|---|---|
Class A | $550 - $660 | 1 month |
Classes B, C & D | $550 - $660 | 3 to 12 months |
产品注册途径
DEVICE CLASS | DESCRIPTION |
|---|---|
Class A | Low risk |
Class B | Low to moderate risk |
Class C | Moderate to high risk |
Class D | High risk |
有用信息
Validity of License: Class A will not expire. Class B, C and D are valid for 5 years.
License transfer: Original registration certificate is needed to transfer license.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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