Medical Devices

Healthcare industry divided over Maharashtra FDA's medical device pricing

Industry bodies back greater scrutiny of medical device pricing but differ on how gaps between hospital procurement costs and prices charged to patients should be assessed

Domestic medtech manufacturers welcome Maha FDA's call for price review

AIMED backing comes after Maharashtra FDA Commissioner Tukaram Mundhe flagged mark-ups of up to 2,841% on medical devices and hospital consumables

CBIC issues checklist for faster clearance of drugs, cosmetics imports

The Central Board of Indirect Taxes and Customs (CBIC) has issued a standardised checklist which a Customs officers will have to follow before clearing import consignments of cosmetics, drugs and medical devices. These products require certain mandatory compliance in terms of licenses, permissions, and registration certificates, as per the provisions of the Drugs and Cosmetics Act, 1940. The checklist follows the Central Drugs Standard Control Organisation (CDSCO)'s measures to facilitate and enhance ease of doing business in these products, the CBIC circular said. These products have been grouped into seven categories -- cosmetics; Drugs in the form of API, finished formulation, import for personal use/import of small quantities of new drug by a medical institution, import for test/analysis. The checklist for medical devices import has been grouped into in vitro diagnostics kits/devices, import of medical devices and import of raw material for manufacture of such devices. "... Th

Refurbished medical device import policy remains under discussion

India's proposed rules for refurbished medical device imports remain unresolved nearly a year after a government panel was formed, amid safety concerns and demand from smaller hospitals

Govt mandates naming sterilisation subcontractors on medical device labels

Domestic firms have raised concerns, saying the move could make Indian medtech exports less competitive

Domestic medtech players seek separate legislation for medical devices

Medical device manufacturers call draft drugs, medical devices and cosmetics bill pharma-centric, misaligned with global medtech norms

Medtech firms seek curbs on third-country rerouting under India-UK CETA

Domestic medical device makers have sought stricter Rules of Origin and customs safeguards under the India-UK CETA to prevent third-country rerouting of imports into India

Govt plans easing licence timelines for moderate, high-risk medical devices

Draft amendments to the Medical Device Rules seek to reduce manufacturing licence timelines for Class B, C and D devices to improve regulatory efficiency and ease of doing business

Centre seeks stakeholder views on medical devices exempt from GTE norms

Department of Pharmaceuticals invites stakeholder comments on proposed additions and deletions to the list of medical devices exempted from Global Trade Enquiry requirements

India could emerge as $7 bn MedTech contract manufacturing hub by 2035

India's overall MedTech opportunity could expand more than fourfold to $83-89 billion by 2035, driven by rising domestic demand, exports and contract manufacturing

Centre eases CME norms for medtech firms under UCMPMD with conditions

New UCMPMD amendment allows overseas training without prior approval in cases where equipment or expertise is unavailable domestically, shifting compliance responsibility to firms

Medical device makers push 'fair pricing' model amid MRP concerns

Medical device makers have urged a shift to a fair pricing model amid concerns over inflated MRPs, even as stakeholders remain divided on pricing practices in healthcare

Parliamentary panel pulls up HealthMin over drug scheme funding gaps

Panel flags funding discontinuity in drug regulation scheme, urges swift SSDRS 2.0 approval and decentralisation of medical device clearances to ease bottlenecks and improve oversight

Medtech, pharma welcome duty relief, seek GST cuts on key inputs

Industry welcomes customs duty exemption on petrochemicals but urges GST relief on inputs and faster refunds to ease cost pressures amid West Asia disruptions

CDSCO asks states to maintain vigil on unlicensed IVF device sales

Regulator flags rise in unlicensed IVF device sales as smaller fertility centres turn to cheaper alternatives amid pricing pressures and lack of awareness

Cyberattack disrupts global networks at US medical device maker Stryker

Stryker, a major US medical equipment company, said a cyberattack disrupted its global networks Wednesday. "We have no indication of ransomware or malware and believe the incident is contained. Our teams are working rapidly to understand the impact of the attack on our systems," Stryker said in a statement on its website. The logo of Handala, a hacking group linked to Iran, has appeared on company login pages, The Wall Street Journal reported. Stryker's statement said the cyberattack hit its Microsoft programs. Emails seeking additional information were not immediately answered. Stryker is based in Portage, Michigan, and makes a variety of medical products, from artificial joints to hospital beds. It had revenue of more than USD 25 billion in 2025. The company says it has 56,000 employees around the world.

Govt seeks views on exempting 350 medical devices from GTE norms

The pharmaceuticals department has invited stakeholder comments on proposed changes to the list of 350-plus medical devices exempt from GTE rules, with submissions open until February

Tariff reset lifts India's medical device pulse amid China+1 shift

US tariff cut lifts Indian medical devices; pharma steady, nutraceuticals seek clarity

Budget 2026-27: Health sector seeks tax relief, rationalised rates

Ahead of Budget 2026-27, healthcare, medtech and pharma firms seek tax relief, higher R&D incentives and stronger support for preventive care and domestic manufacturing

Drug regulator mandates CDSCO licensing on medical device procurement

The regulator told states not to demand USFDA or EU approvals in tenders after complaints that Indian-made devices were being sidelined