Baird Medical Investment Holdings Limited (NASDAQ: BDMD) received Class III registrations for its microwave ablation (MWA) system and single‑use needles from the Drug Regulatory Authority of Pakistan’s Medical Device Board and the Ministry of Health’s Infrastructure and Medical Device Administration in Vietnam. The approvals, announced on January 7, 2026, allow the company to market its core MWA platform in two of the world’s fastest‑growing healthcare markets.
The registrations confirm that Baird’s MWA technology meets the stringent safety and efficacy standards required for high‑risk medical devices in both countries. In Pakistan, the Medical Device Board requires a five‑year registration for Class III devices, while Vietnam’s classification system places MWA systems in the highest risk category, necessitating a comprehensive technical dossier and local marketing authorization holder. The approvals therefore represent a significant regulatory hurdle cleared for the company’s flagship product line.
Pakistan’s thyroid market is projected to grow at a compound annual growth rate of 8.5% over the next decade, driven by rising prevalence of benign nodules and increasing public and private payer coverage for minimally invasive procedures. Vietnam’s outpatient surgery market is expected to expand at 12% annually, with government initiatives to reduce inpatient stays and promote cost‑effective treatments. By entering these markets, Baird positions itself to capture a share of the projected $1.2 billion regional MWA opportunity, complementing its existing presence in over 20 countries.
Baird’s revenue in 2024 reached $37.04 million, up 17.7% from the prior year, reflecting strong demand in its core Chinese market and early traction in the United States following FDA 510(k) clearance. The company’s management highlighted that the new approvals will diversify its revenue base and reduce concentration risk in China, where regulatory and competitive pressures are intensifying. Chairwoman Haimei Wu stated, “Securing these approvals in Pakistan and Vietnam is a pivotal step in our international expansion, opening new avenues for growth and reinforcing our commitment to delivering life‑saving technology worldwide.”
The regulatory milestones also support Baird’s broader strategy of establishing a U.S. manufacturing base through a partnership with MPS Medical and appointing a new U.S. CEO. Together, these moves aim to scale production, reduce lead times, and strengthen supply chain resilience, positioning the company to meet rising global demand for MWA systems as the market for minimally invasive ablation therapies continues to expand.
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