India’s medical device market could be heading for a major shift if regulators allow hospitals to import high-end diagnostic equipment directly from overseas manufacturers, bypassing the licensed importers that currently dominate the channel.
The proposal, being examined by the Central Drugs Standard Control Organisation, would affect a wide range of sophisticated devices, including MRI scanners, CT scanners, PET-CT systems and mammography units. These products fall into Clas...
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s C and Class D under India’s medical device framework, the higher-risk categories recognised by the CDSCO, which oversees import, manufacture and sale under the Drugs & Cosmetics Act and the Medical Devices Rules, 2017.
According to Medical Buyer, the change is being considered because the existing system can slow procurement and add cost. Hospitals, especially large private chains, often argue that they should not have to route purchases through intermediaries when dealing directly with global manufacturers. That case has become more compelling as the government seeks to modernise healthcare infrastructure and expand diagnostic capacity.
The current import regime is not light-touch. CDSCO guidance and industry explainers note that importing medical devices into India generally requires registration, an import licence and documentation submitted through the SUGAM portal, a process that can take months. For foreign manufacturers, the usual route also involves an Indian authorised agent. In practice, that means hospitals buying through the established system depend on a regulatory and logistics chain that can be slow but is designed to maintain oversight.
For large hospital groups, direct importing could bring quicker access to new technology, stronger bargaining power and more room to negotiate service arrangements with manufacturers. It could also help public hospitals, if they are eventually included, bring in equipment more quickly than under conventional procurement channels.
But the change would not be uniformly welcomed. Licensed importers and distributors could see part of their business model erode if hospitals begin dealing directly with manufacturers. Domestic device makers may also face tougher competition if foreign brands gain a more direct route into Indian hospitals and deepen their commercial relationships there.
The biggest concern, however, is not commercial but clinical. Class C and Class D devices are high-risk for a reason: they need correct installation, calibration and maintenance. Under the current model, importers typically carry after-sales support obligations as part of their regulatory role. If hospitals are allowed to import directly, the CDSCO will have to make clear what technical competence, biomedical engineering capacity and maintenance arrangements a hospital must have before it can take on that responsibility.
That matters because the apparent savings from direct import may not be as large as they first seem. Hospitals would still need to manage customs clearance, installation, training and long-term servicing, costs that are often bundled by distributors into a single price. For institutions without strong procurement and technical teams, the administrative burden could offset some of the hoped-for gains.
For now, the key issue is how far the final notification goes. A narrow, carefully controlled policy could speed up access to advanced equipment without weakening patient safety. A broader liberalisation, without firm qualification standards, could leave hospitals carrying more compliance risk than they are prepared for. Either way, the proposal signals a potentially significant change in how India sources some of its most complex medical technology.
Source: Noah Wire Services
