India-New Zealand FTA to Propel MedTech Sector, Yet Regulatory Gaps Remain, ETHealthworld
New Delhi: The Free Trade Agreement (FTA) between India and New Zealand, is expected to give strong push to MedTech firms in India and experts believe the deal to reduce compliance burdens, improve market access, and boost the competitiveness of exports.
Welcoming the announcement, Rajiv Nath, Forum Coordinator, AiMeD., said “the deal opens a strategic opportunity for the medical devices sector. Reduced tariffs and streamlined regulatory cooperation will boost exports, enhances competitiveness for Indian manufacturers.”
Reflecting on the FTA’s regulatory breakthrough, Pavan Choudary, Chairman, Medical Technology Association of India, (MTaI), said, with New Zealand agreeing to recognize GMP and GCP inspection reports from the US FDA, the EU’s EMA, and the UK’s MHRA, reducing duplicative compliance burdens and accelerating product approvals for Indian manufacturers.
“However, framework does not yet include India’s own Central Drugs Standard Control Organization (CDSCO) and the deal, must correct this omission,” Choudary added.
Choudary asserted that, the CDSCO is rapidly maturing into a credible, reference-class regulator and such bilateral recognition frameworks is a commercial and strategic imperative.
India’s regulator has undertaken several steps to align its standards with global benchmarks. In 2024, CDSCO became an affiliate member of the International Medical Device Regulators Forum (IMDRF), which supports harmonization of regulatory standards to reduce the complexity for manufacturers and prioritize patients interest.
