The American Chamber of Commerce in Bangladesh (AmCham) has urged the government to introduce separate Directorate General of Drug Administration (DGDA) guidelines for medical devices, with defined registration timelines and lower duties and taxes.
State Minister for Health Dr MA Muhit has acknowledged delays in approvals and said the government is working to expedite them.
The chamber made the call at a roundtable, titled "Unlocking the Potential of Medical Technology to Improve Patient Outcomes in Bangladesh", in Dhaka today (19 October). Senior government officials, US Embassy representatives, and business leaders from AmCham's medical technology member companies attended the event.
AmCham presented five recommendations for the government's consideration: separate DGDA guidelines for medical devices; streamlined registration with defined timelines and parallel dossier reviews; predictable MRP approvals consistent with the mark-up guideline and 7.5% VAT; rationalisation of duties and taxes on medical devices and spare parts; and simpler provisions for re-exporting equipment for repairs and importing spare parts.
As a longer-term step, the chamber proposed a joint workshop with the DGDA, American and European medical technology companies, and other stakeholders to explore a dedicated regulatory framework aligned with international standards and best practices.
Addressing the roundtable, Muhit said the government's priorities include strengthening primary healthcare, disease prevention, and decentralising specialised services to divisional and district levels.
Citing the record health budget of around Tk70,000 crore and recent tax measures, he acknowledged registration delays and reaffirmed the government's efforts to speed up approvals.
He urged US companies to pursue sustainable partnerships beyond equipment sales, emphasising lifecycle costs, after-sales support, technology transfer, local manufacturing and assembly, and specialised training for Bangladeshi engineers and healthcare professionals, including those from Bangladesh University of Engineering and Technology and Dhaka University.
The state minister also announced plans for a national e-health and digital monitoring dashboard to make better use of medical equipment, alongside innovative financing and transparent procurement. He asked multinational companies to use their CSR initiatives to support underserved communities, particularly children with disabilities.
AmCham President Syed Mohammad Kamal said member companies have invested over $5 billion in Bangladesh and have committed to facilitate another $5 billion over the next five years. He said healthcare and medical technology could help advance this ambition through innovation, capacity building, and better patient care.
Outlining the directorate's regulatory priorities and reforms, DGDA Director General Md Alamgir Hossain said they are working to streamline registration procedures and to facilitate the resumption of inspections by international regulators, stressing the need for timely, transparent, and predictable approvals.
Dr Omar Ishrak, former chairman and CEO of Medtronic PLC and former chairman of Intel Corporation, spoke on global trends in medical technology and the opportunities for Bangladesh to use technological advances to expand access to quality care and improve patient outcomes.
Several representatives of AmCham member companies, including Mayank Tripathi, country director of Medtronic Bangladesh; Mirza Shajib Raihan, business leader for Bangladesh at Becton Dickinson; and Muhammad Asaduzzaman Romel, country head and director of GE HealthCare Bangladesh, spoke during the discussion, which Paul Frost, the commercial counselor at the US Embassy in Dhaka, and other embassy officials also joined.
Welcoming the government's constructive approach to dialogue, participants reaffirmed their commitment to working with the Ministry of Health and Family Welfare and the DGDA to build a transparent, predictable, and enabling regulatory environment for medical technology.
AmCham Executive Director Chowdhury Kaiser Mohammad Riyadh moderated the event. Al-Mamun M Rashel, country manager and managing director of NATCO Bangladesh, delivered the vote of thanks. The event was supported by Medtronic Bangladesh.