Lord’s Mark strengthens UK and UK allied market strategy with regulatory backing for IVD portfolio.

Regulatory approvals have become an increasingly important enabler for healthcare and medical technology companies seeking to expand into international markets, particularly as demand grows for products that meet established safety, quality and performance standards. In the UK, registration with the Medicines and Healthcare Products Regulatory Agency (MHRA) provides companies with an important regulatory foothold as they look to build market access and strengthen their presence across the country and allied markets. Against this backdrop, Lord’s Mark Industries Limited has secured another regulatory milestone, with its In-Vitro Diagnostic (IVD) portfolio registered with the MHRA, days after announcing the UK registration of its AI-powered Renalyx haemodialysis system, further advancing its plans to establish a broader healthcare and diagnostics presence across the UK and UK-allied markets.

The latest registration, dated September 24, 2026, records Lord’s Mark Industries as a registered manufacturer and covers IVD categories including haematological cell analysers, multiple clinical chemistry analysers, buffered sample diluents and instrument/analyser cleaning agents.

The development comes shortly after the company’s MHRA registration for its AI-powered haemodialysis system, announced in September, which marked its planned entry into the UK and UK-allied markets. The successive registrations now broaden that international roadmap from renal-care technology to diagnostics, creating the foundation for a wider healthcare portfolio in the region.


Lord’s Mark Industries plans to commence commercial sales of its IVD products in the UK from December 2026, approximately two months ahead of its earlier planned schedule. The company intends to leverage the UK market as an important international platform while pursuing opportunities across UK-allied markets, subject to applicable regulatory requirements in each jurisdiction.

The company is simultaneously expanding beyond product exports into healthcare delivery. Lord’s Mark Industries plans to commence operations of its pathology laboratory from January 2027, creating an additional platform for diagnostic services and supporting its broader vision of integrating diagnostic products, laboratory capabilities and healthcare delivery.

With the latest MHRA registration, December 2026 commercialisation and January 2027 pathology-lab launch, Lord’s Mark Industries is positioning its UK expansion as an integrated healthcare strategy rather than a single-product market entry bringing together IVDs, advanced medical technology and diagnostic services.

Dr. Sachidanand Upadhyay, MD & CEO, Lord’s Mark Industries Limited, said: “Our recent MHRA registration for the Renalyx haemodialysis system opened an important door for us in the UK and UK- allied markets. This latest registration for our IVD portfolio demonstrates that our ambition extends well beyond a single healthcare product. We are building a broader diagnostics and healthcare platform, with commercialisation now planned two months ahead of schedule, followed by the launch of our pathology laboratory in January 2027.”

The UK government states that medical devices, including IVDs, must be registered with MHRA before they can be placed on the Great Britain market, making the registration an important regulatory step towards commercialisation¹.

The latest regulatory milestone marks another step forward in Lord’s Mark Industries’ broader international expansion, reinforcing its focus on taking Indian-developed healthcare technologies and diagnostic capabilities to markets beyond India. With its growing regulatory footprint and expanding portfolio, the company is positioned to pursue new market opportunities, deepen its presence across international healthcare ecosystems and build a stronger global platform for its products in the years ahead.

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Reference:
1. https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

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