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Tag: medical devices

  • AmCham Pledges $5 Billion as Bangladesh Seeks US Healthcare Tie-Up

    AmCham Pledges $5 Billion as Bangladesh Seeks US Healthcare Tie-Up

    Bangladesh is courting US medical device makers for local assembly and technology transfer, backed by a national healthcare budget of roughly Tk 70,000 crore. The push aims to draw multinational manufacturers deeper into domestic supply chains rather than relying purely on direct imports.

    State Minister for Health and Family Welfare MA Muhit presented the proposal during an industry roundtable in Dhaka organised by the American Chamber of Commerce in Bangladesh in October 2026. AmCham President Syed Mohammad Kamal highlighted over $5 billion in existing investments and pledged to facilitate another $5 billion over the next five years.

    What Dhaka Wants from US Tech Providers

    Government officials want overseas suppliers to set up local assembly plants, train Bangladeshi engineers, and support equipment across its entire lifecycle. The initiative targets technical institutions including Bangladesh University of Engineering and Technology and the University of Dhaka to build domestic servicing capacity.

    Dhaka is also preparing a national digital monitoring dashboard and e-health system to track how state hospitals use medical machinery. Muhit told company executives that procurement must shift toward transparent contracts and structured after-sales support.

    Regulatory Roadblocks for Device Makers

    Multinational executives at the meeting pressed the government to remove persistent administrative bottlenecks at the Directorate General of Drug Administration. Lengthy approval cycles and import frictions continue to delay shipments of critical hospital equipment and replacement parts.

    AmCham submitted five specific policy demands to streamline market access. The business group called for separate DGDA guidelines for medical hardware, clear registration deadlines with parallel dossier reviews, and predictable maximum retail price formulas aligned with markup rules and the 7.5 percent value-added tax.

    Supply Chain and Tax Reforms

    Device suppliers face high import tariffs on spare components and burdensome customs procedures when sending damaged machinery abroad for maintenance. Industry leaders want tax rationalisation and simpler rules for re-exporting equipment for overseas repairs.

    Country heads from GE HealthCare, Medtronic, and Becton Dickinson attended the discussions alongside US Embassy commercial counsellor Paul Frost and DGDA director general Md Alamgir Hossain. For foreign vendors, local assembly offers protection against currency swings and import restrictions, but high tariffs on sub-assemblies still erode operating margins.

    The Next Regulatory Step

    Dhaka previously lowered select healthcare duties to ease hospital costs, yet device classification rules remain tied to general pharmaceutical standards. That shared framework creates administrative backlogs because diagnostic hardware requires different safety certifications than consumer drugs.

    AmCham is now organising a joint technical workshop with the DGDA and Western medical device manufacturers to draft an international-standard regulatory framework for hospital technology.

  • Singapore Expands Drug Regulatory Alliances Across Malaysia, Middle East and Africa

    Singapore Expands Drug Regulatory Alliances Across Malaysia, Middle East and Africa

    Singapore’s Health Sciences Authority signed cross-border regulatory pacts with counterparts in Saudi Arabia and Africa. At the same time, Malaysia began piloting Singaporean medicine assessments to speed up commercial drug clearances.

    The pilot with Malaysia’s National Pharmaceutical Regulatory Agency started on 1 September 2026. It establishes a formal reliance framework to eliminate duplicate clinical reviews across both markets.

    Under the bilateral trial, Malaysia’s agency is evaluating whether referencing evaluations by Singapore’s Health Sciences Authority can shorten review timelines without lowering safety or efficacy benchmarks. A successful trial will prompt Malaysia to designate Singapore as an official reference agency. That step would give drugmakers with Singaporean clearances an accelerated registration route in Kuala Lumpur.

    Faster approvals across ASEAN

    For pharmaceutical distributors, biotechs, and consumer healthcare brands, duplicative licensing remains a costly barrier to scaling products across Southeast Asia. Fragmented national registries across ASEAN historically forced manufacturers to submit separate dossiers. Companies then had to wait out multi-year evaluation cycles in each domestic market.

    Singapore’s push to become an international evaluation hub shifts that dynamic for regional supply chains. Under mutual reliance models, regional health agencies replace independent full-scale assessments with shared technical oversight. This cuts administrative overhead for suppliers and speeds up treatment rollouts in retail pharmacies and hospitals.

    Bilateral deals with Riyadh and the African Union

    Beyond Southeast Asia, HSA signed two agreements between 14 and 16 September 2026. The agency inked a memorandum of understanding with the Saudi Food and Drug Authority to exchange pre-market and post-market safety data. The deal also builds regulatory pathways for biotechnology and artificial intelligence applications in healthcare.

    The second agreement, signed with the African Medicines Agency, creates a cooperative framework covering regulatory science, capacity development, and technical reviews. Under the pact, African regulators can use Singaporean approvals as technical benchmarks for national decisions across member states.

    “A medicine or medical device should not have to wait because trusted regulators are repeating the same high-quality work,” HSA CEO Raymond Chua said. “By enabling partners to draw on HSA’s assessments, we can reduce duplication, support more timely access to safe and effective health products, and help innovators reach patients across more markets.”

    Expanding European lab standards

    Ties with European and British authorities also expanded. Following a joint audit, the European Directorate for the Quality of Medicines and HealthCare extended Singapore’s associate membership in the General European Official Medicines Control Laboratory Network to include the city-state’s National Biologics Testing Laboratory.

    The European accreditation allows Singapore to participate in global testing programs for complex biological drugs. At the same time, Singapore and the UK Medicines and Healthcare products Regulatory Agency reaffirmed their Regulatory Innovation Corridor. Opened in December 2025, the initiative gives developers of novel drugs early, iterative regulatory guidance across both jurisdictions.

    The timeline for regulatory convergence

    During its 2026 chairmanship of the International Medical Device Regulators Forum, Singapore delivered an operational playbook for regulatory reliance. It also released technical frameworks for artificial intelligence in medical devices and product cybersecurity. In addition, HSA deployed a large language model tool built with GovTech Singapore to map medical device adverse event reports directly to global classification standards.

    Regulators in Kuala Lumpur will track data from the reference pilot over the coming quarters. Their findings will determine whether to formalize Singapore’s status as a permanent reference agency for Malaysian drug registrations.

  • Gleneagles Hospital Completes Hong Kong’s First 2 Histotripsy Cancer Trials

    Gleneagles Hospital Completes Hong Kong’s First 2 Histotripsy Cancer Trials

    In April, Gleneagles Hospital carried out Hong Kong’s first two clinical trial procedures using histotripsy to destroy pancreatic cancer tumours in patients for whom conventional surgery was unsuitable.

    In one case, doctors targeted both the primary pancreatic tumour and cancer that had spread to the liver during the same procedure using precisely targeted sound waves.

    Clinical rollouts and equipment targets

    Dr Neal Kassell, founder and chairman of the US-based Focused Ultrasound Foundation, estimated that clinical trial results for pancreatic and brain cancers could emerge in about three years, predicting global machine deployments could rise from roughly 2,000 to 10,000 systems within five years.

    Clinical evidence covers 196 potential medical indications across neurology, oncology, and pharmacology, according to data from the Focused Ultrasound Foundation. Twelve of those indications advanced to first-in-human clinical trials last year. More than one million patients have received focused ultrasound therapies globally to date, with annual treatment volumes reaching approximately 75,000 cases.

    Treatment pricing and hospital economics

    Hospital operators face steep upfront hardware costs and slow physician onboarding. In Hong Kong, treatment access relies heavily on private philanthropy to bridge gaps in public health insurance. Eligible liver cancer patients receiving histotripsy at Gleneagles pay HK$50,000 (US$6,374) under a subsidy funded by the Li Ka Shing Foundation.

    Specialist consultations and preliminary liver ultrasound assessments add between HK$4,300 and HK$5,400 to out-of-pocket patient expenses. Without formal public reimbursement or standardised private insurance schedules, hospital adoption across private healthcare chains in Southeast Asia and East Asia remains confined to flagship research centres.

    Overcoming the blood-brain barrier

    Beyond thermal and mechanical tumour ablation, clinical teams are testing low-intensity sound waves to deliver pharmaceuticals directly into brain tissue. The acoustic waves stimulate microscopic bubbles in the bloodstream, prompting them to expand and contract against capillary walls. This rhythmic motion creates a temporary opening in the blood-brain barrier, allowing chemotherapies and immunotherapies to reach aggressive conditions such as diffuse midline glioma and glioblastoma.

    Opening this barrier allows oncologists to test compounds that previously failed clinical trials simply because molecules could not penetrate the central nervous system. Combining acoustic opening with local immune responses also provides a pathway to turn drug-resistant brain tumours into active targets for immunotherapy.

    Reimbursement pathways and regulatory hurdles

    Commercial viability for medical equipment makers in Asia depends on moving beyond self-pay arrangements. Most private medical centres keep focused ultrasound machinery under capacity because few surgeons have received specialised training on acoustic ablation consoles.

    The critical financial hurdle remains insurance coding. Until state healthcare panels and major medical underwriters establish specific reimbursement tariffs for focused ultrasound oncology procedures, equipment makers will struggle to convert trial successes into steady device sales across regional hospital groups.

    Global trials assessing overall survival rates and recurrence intervals in pancreatic cancer and glioblastoma are scheduled to release primary outcome data within the next three years.