Medical device traders demand independent law to ease imports

Leaders of medical device traders' associations have demanded the devices be kept out of the purview of the existing Drug and Cosmetics Act 2023 to simplify its import and reduce medical expenses.

At a press conference held at Jatiya Press Club yesterday under the banner of the medical device traders' associations' alliance, they also called for formulation of an independent law and time-befitting regulations regarding medical devices, as well as formation of a stakeholder committee to this end.

In addition, they also demanded reducing the registration fee for imported medical devices at the Directorate General of Drug Administration.

The event was attended by the representatives from the Diagnostic Reagent and Equipment Traders Association of Bangladesh, Bangladesh Medical Equipment Importers and Suppliers Association, Bangladesh Medical Instrument and Hospital Equipment Dealers and Manufacturers Association, BMA (Bangladesh Medical Association) Bhaban Shop Owners' Welfare Association.

They said currently, 98% of the country's medical devices are import-dependent. As per the Drug and Cosmetics Act 2023, while importing a device, it requires a recipe approval from the regulator, which they described as "completely unreasonable".

Recipe approval is a regular process to register foreign/new medicines at the Directorate General of Drug Administration to ensure that the drug is safe, effective and meets standards. 

In addition, though the imported devices are mostly US-FDA/CE/ISO certified, the existing law obligates submission of a free sale certificate (FSC) attested by the Bangladesh embassy of the export country to the regulator.

The process is time-consuming and unreasonable, said traders.

They added that before issuing a letter of credit (LC) every time, the importer has to secure indent approval from the Drug Administration Directorate, further delaying the usual import process.

Separate laws and time-befitting regulations should be formulated to simplify the registration of all types of medical devices, equipment and diagnostic reagents, in a bid to ensure quality and proper management, and improved medical services for the people, said leaders of the associations.

To formulate the regulations, they also demanded a committee comprising members of medical device/product traders' associations, diagnostic and hospital owners' associations, as well as relevant experts.

Additionally, they also demanded a separate unit involving relevant experts to simplify the medical devices' registration by abolishing the existing obligations of recipe approval, indent approval, and free-sale certificate verification processes.

They said currently the registration fee for each medical device/product stands at approximately Tk65,000, which leads to a rise in the price, resulting in heightened medical expenses.

Considering the country's socio-economic context, they demanded the registration fee be reduced to Tk1,000 for "class A" devices, Tk5,000 for "class B" ones, Tk10,000 for "class C" and Tk15,000 for "class D" products.