Medical Devices

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

Biorad Medisys works on 'pacemaker' for managing diabetes with VNS tech

Pune-based Biorad Medisys is developing an implantable vagus nerve stimulation device that aims to improve insulin balance, regulate hunger, and support obesity care without drugs or chemical compound

Inviga Healthcare buys 21% stake in medical equipment maker Forus Health

The transaction underscores Inviga's commitment to supporting world-class, AI-driven diagnostic solutions conceived and built in India for global scale

CDSCO issues draft guidelines to regulate medical device software

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML evaluation and algorithm change management

Govt to broaden qualification criteria to recruit medical device inspectors

The ministry has issued a draft notification proposing an amendment to add qualifications for inspectors and government analysts under Rule 18 of the Medical Device Rules (MDR), 2017

NPPA extends knee implant price ceiling till November 2025 amid review

The NPPA has extended the ceiling price for knee implants till November 2025 while considering industry pleas for removal, citing rising costs and supply chain issues

Medical device makers ask for extending ITC on services, capital goods

Industry body Aimed says proposed balanced reforms could help reduce healthcare costs for consumers

Pharma, medtech bodies seek transition time and simpler refunds

Industry bodies asked the govt for a three-month transition period, use of old packaging, and a simpler GST refund mechanism to avoid supply chain disruptions in healthcare

Patients to benefit from GST rate cut, but firms likely to face pressure

GST rationalisation lowers costs for medical consumables and high-end therapies, benefiting patients. However, pharma companies, particularly in biologics, may face margin pressure due to ITC loss

Prices of diagnostic tests unlikely to change much despite GST rate cut

GST reduction on medical devices, diagnostic kits, and reagents is a welcome move, but leading diagnostic players believe test prices will remain largely unaffected due to minimal changes

GST on lifesaving drugs reduced to nil: Check full list of tax on medicines

GST Council meet outcome: GST on various medical apparatus and devices used for medical, surgical, dental or veterinary usage has been reduced to 5% from 12%

Safety with affordability: New rules on medical devices should balance them

Imports should be restricted to original manufacturers or certified partners, while devices that are too old or have exceeded usage thresholds should be barred

Competitiveness may be hit on GST rejig: Medical devices industry

AIMED said GST changes could hurt domestic medtech competitiveness and tilt the market towards imports, urging balanced tax slabs, refund reforms, and a higher Health Cess

Govt panel starts drafting rules for refurbished medical device imports

A high-level inter-departmental committee has begun discussions on regulating refurbished medical devices, balancing patient safety concerns with affordable healthcare access

Govt, industry hold talk on issues over marketing code for medical devices

Medical device companies raise issues with the DoP over UDMPMD norms related to disclosure of training expenses and restrictions on overseas training approvals

CDSCO relaxes loan license requirement for med device sterilisation

Medical device makers can now outsource sterilisation through third-party agreements without loan licences if the facility holds a valid sterilisation licence

Renalyx launches smart dialysis unit RxT21, plans ₹800 crore boost

Renalyx Health Systems launches AI-enabled dialysis machine RxT21 with real-time monitoring at ₹6.7 lakh, plans to scale production and expand into global markets

EU votes to curb Chinese medical devices, cites procurement bias

The move comes after the EU, in its investigation, found that Beijing discriminated against foreign firms in procurement of medical devices

Centre to aid development of indigenous thrombectomy device for stroke

Technology Development Board to fund S3V Vascular Technologies for manufacturing India's first thrombectomy device, aiming to reduce import dependency and boost stroke care

Sun Pharma gets USFDA approval for new device to treat skin disease

The company says that the new device is more compact and easier to use than its predecessor