AmCham seeks dedicated regulations for medical technology

The American Chamber of Commerce in Bangladesh (AmCham) has called for a dedicated regulatory framework for medical devices and equipment to improve healthcare access and patient outcomes in the country.

The call came at a high-level roundtable titled “Unlocking the Potential of Medical Technology to Improve Patient Outcomes in Bangladesh” held in Dhaka on Monday.

The event brought together senior government officials, US Embassy representatives and business leaders from AmCham’s medical technology member companies to discuss regulatory reforms for the sector.

AmCham President Syed Mohammad Kamal reaffirmed the chamber’s commitment to strengthening Bangladesh-US economic ties, highlighting more than $5 billion in existing investments by member companies and its ambition to facilitate another $5 billion over the next five years.

He said healthcare and medical technology could contribute to this goal through innovation, capacity building and improved patient care.

At the roundtable, AmCham presented five policy recommendations to the government to establish a more transparent, predictable and business-friendly regulatory environment.

The recommendations included separate Directorate General of Drug Administration (DGDA) guidelines for medical devices, faster registration with defined timelines, parallel reviews of registration dossiers, predictable maximum retail price (MRP) approvals in line with markup guidelines and 7.5% VAT, rationalisation of duties and taxes on medical devices and spare parts, and simplified rules for re-exporting equipment for repairs and importing spare parts.

AmCham also proposed a joint workshop involving the DGDA, American and European medical technology companies and other stakeholders to develop a dedicated regulatory framework aligned with international standards and best practices.

DGDA Director General Md Alamgir Hossain said the authority was working to streamline registration procedures and facilitate the resumption of inspections by international regulators. He stressed the importance of timely, transparent and predictable regulatory approvals.

State Minister for Health and Family Welfare M A Muhit, MP, attended the roundtable as the chief guest. He outlined the government's priorities, including strengthening primary healthcare, preventing diseases and decentralising specialised services to divisional and district levels.

Referring to the health budget of approximately Tk70,000 crore and recent tax measures, he acknowledged delays in regulatory registration and reaffirmed the government's efforts to expedite approvals.

He urged US companies to pursue sustainable partnerships beyond equipment sales, emphasising lifecycle costs, after-sales services, technology transfer, local manufacturing and assembly, and specialised training for Bangladeshi engineers and healthcare professionals, including those from BUET and the University of Dhaka.

He also highlighted plans for a national e-health and digital monitoring dashboard to improve medical equipment utilisation, alongside innovative financing and transparent procurement.

Emphasising inclusive healthcare, the state minister called on multinational companies to use their corporate social responsibility initiatives to support disadvantaged communities, particularly children with disabilities.

Omar Ishrak, former chairman and chief executive officer of Medtronic plc and former chairman of Intel Corporation, shared his views on emerging medical technologies and the opportunities for Bangladesh to expand access to quality healthcare and improve patient outcomes.

Industry representatives, including Medtronic Bangladesh Country Director Mayank Tripathi, Becton Dickinson Business Leader for Bangladesh Mirza Shajib Raihan, and GE HealthCare Bangladesh Country Head and Director Muhammad Asaduzzaman (Romel), also shared their perspectives.

Paul Frost, commercial counsellor at the US Embassy in Dhaka, and other embassy officials participated in the discussion.

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Participants welcomed the government's approach to dialogue and reaffirmed their commitment to working with the Ministry of Health and Family Welfare and the DGDA to establish a transparent, predictable and enabling regulatory environment for medical technology.

The roundtable was moderated by AmCham Bangladesh Executive Director Chowdhury Kaiser Mohammad Riyadh, while NATCO Bangladesh Country Manager and Managing Director Al-Mamun M Rashel delivered the vote of thanks. Medtronic Bangladesh supported the event.