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The Ministry of Health and Family Welfare has amended the Medical Devices Rules, 2017 on two counts, notified through the Official Gazette, to simplify compliance in the medical device sector.
Rule 44 has been amended so that a manufacturer outsourcing sterilisation to another facility that already holds a valid licence under the Rules no longer needs a separate loan licence for that activity; a six-month transition period applies to the accompanying labelling requirement.
Rule 63 has been amended to add the European Union to the list of recognised stringent regulatory jurisdictions whose approval can waive clinical investigation requirements for medical devices without a predicate device.
The list previously recognised the United States of America, the United Kingdom, Australia, Canada and Japan; with the EU added, it now runs to six jurisdictions.
The stated aims are reduced duplication and compliance cost for manufacturers without in-house sterilisation, faster patient access to advanced devices, and stronger international regulatory convergence.
The parent statute. Medical devices in India are regulated as 'drugs' under this Act, which is why the device rules are subordinate legislation under it rather than a standalone device law.
The operative rules for manufacture, import, sale and clinical investigation of medical devices. They introduced the risk-based classification into Classes A, B, C and D, and it is Rules 44 and 63 that have now been amended.
Governs outsourced sterilisation. A manufacturer sending devices to a licensed sterilisation facility is no longer required to hold a separate loan licence for that activity.
Governs waiver of clinical investigation for devices without a predicate device on the strength of approval by a recognised stringent regulatory jurisdiction. The European Union has now been added to that list.
A LOAN LICENCE is a licence to use somebody else's licensed premises and equipment for a manufacturing step. Because sterilisation is part of manufacture, a company that sent its devices out to be sterilised previously needed its own loan licence for that facility, duplicating a licence the sterilising unit already held. A PREDICATE DEVICE is an already-approved device that is substantially equivalent to a new one; where a predicate exists, a new device can be cleared by comparison instead of fresh clinical investigation. Where no predicate exists, evidence has to come from somewhere else — which is where a STRINGENT REGULATORY AUTHORITY comes in: a regulator whose approval process India treats as good enough to substitute for a domestic clinical investigation. Adding the EU means a device already cleared under EU rules can use that clearance in India, which is what 'regulatory convergence' means in practice.
Simple Analogy: The predicate device is a precedent already on the record; the stringent regulator is a court whose judgments you agree to recognise; the loan licence was a second permit to use a workshop that was already licensed.
India's national regulatory authority for drugs, cosmetics and medical devices, functioning under the Directorate General of Health Services, Ministry of Health and Family Welfare. It administers the Medical Devices Rules, 2017 and the risk-based classification of devices.
Head of CDSCO; the licensing authority for import and manufacture of higher-risk medical devices (Classes C and D) and for new drugs and clinical trials. State Licensing Authorities handle Class A and B devices.
The ministry that notifies amendments to the Medical Devices Rules through the Official Gazette and sets policy for the sector alongside the Department of Pharmaceuticals.
| Class | Risk level | Typical examples | Licensing authority |
|---|---|---|---|
| Class A | Low | Bandages, surgical masks, examination gloves, tongue depressors | State Licensing Authority |
| Class B | Low to moderate | Hypodermic needles, suction equipment, nebulisers | State Licensing Authority |
| Class C | Moderate to high | Bone fixation implants, heart valves, intraocular lenses | Central Licensing Authority (DCGI/CDSCO) |
| Class D | High | Pacemakers, defibrillators, implantable stents | Central Licensing Authority (DCGI/CDSCO) |
Grow India's medical device sector and cut import dependence
Key: Approved by the Union Cabinet in 2023; targets growth from about USD 11 billion to USD 50 billion by 2030 through six policy strands — regulatory streamlining, enabling infrastructure, R&D and innovation, attracting investment, human resource development, and brand positioning. The Rule 44 and Rule 63 amendments sit squarely in the first strand.
Build domestic manufacturing in high-value device segments
Key: Outlay of Rs 3,420 crore covering four target segments — cancer care and radiotherapy devices, radiology and imaging devices, anaesthetics and cardio-respiratory devices, and implants — running from FY 2020-21 to FY 2026-27.
Create a device-specific regulatory regime distinct from ordinary drug licensing
Key: Introduced risk-based classification (Classes A to D), separate central and state licensing tiers, and the clinical investigation framework that Rule 63 now relaxes for EU-approved devices.
The split between State Licensing Authorities for Class A and B devices and the Central Licensing Authority for Class C and D mirrors the shared central-state responsibility that runs through the Drugs and Cosmetics Act, 1940.
India imports a large share of high-end medical devices; the National Medical Devices Policy 2023 and the PLI scheme both target that dependence, and the regulatory amendments are the low-cost lever in the same programme.
Removing duplicated licences is the standard template of India's EoDB agenda — the same logic as decriminalisation of minor compliance offences and single-window clearances in other sectors.
GS Paper 2 > Governance > Statutory and Regulatory Bodies; GS Paper 3 > Indian Economy > Industrial Policy
General Awareness > Polity and Current Affairs
Moderate — health regulators and the device policy recur in governance and economy questions.
A licence permitting a manufacturer to use another entity's licensed premises and equipment for a manufacturing step — now not required for outsourced sterilisation at an already-licensed facility.
An already-approved device substantially equivalent to a new one, allowing the new device to be cleared by comparison rather than fresh clinical investigation.
A foreign regulator whose approval India recognises as sufficient to waive domestic clinical investigation; now the USA, UK, Australia, Canada, Japan and the European Union.
The Medical Devices Rules, 2017 system grading devices A (low risk) to D (high risk), which determines the licensing authority and evidence requirements.