Panel Recommends Decentralisation of Medical Device Licensing to SLAs
Overview - Decentralisation of Medical Device Licensing
The Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended decentralising the licensing of Class A and B medical devices to State Licensing Authorities (SLAs) to strengthen the regulatory framework and encourage global medical device companies to establish manufacturing facilities across Indian states.
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Greater Autonomy for State Licensing Authorities
In its 176th report on the affordability and accessibility of healthcare, the Committee recommended giving SLAs greater autonomy to license medical devices based on quality assessments conducted by notified laboratories approved by the Quality Council of India (QCI).
The Committee noted that decentralisation could help states develop positive regulatory mechanisms and compete to attract global manufacturers, strengthening India’s medical device manufacturing ecosystem.
Medical Device Licensing in India
Under the Medical Devices Rules (MDR), 2017, CDSCO has licensed 3,480 manufacturing units for Class A and B devices and 1,100 for Class C and D devices. It has also approved 12,866 import licence applications as of July 1, 2026.
Read more about CDSCO Medical Device Classifications.
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Focus on Licensed Medical Device Procurement
The Committee highlighted the need for strict enforcement of the November 25, 2025 procurement mandate, which requires hospitals and healthcare institutions to procure medical devices only from suppliers holding valid CDSCO or SLA licences.
Expanding Medical Device Testing Infrastructure
The Committee recommended that states make greater use of their powers under the MDR, 2017 to establish additional Medical Device Testing Laboratories (MDTLs).
Expanding beyond the existing 84 MDTLs and 18 Notified Bodies, along with better deployment of 258 notified Medical Device Officers, could strengthen domestic quality assurance.
Strengthening India’s Medical Device Regulatory Framework
Overall, the Committee called for greater SLA autonomy, stronger testing infrastructure, and technology-driven regulatory oversight to ensure that safe, compliant, and high-quality medical devices reach patients across India.
Role of Operon Strategist
Operon Strategist helps medical device companies navigate India’s evolving regulatory landscape through:
- CDSCO & SLA Compliance: Guidance on medical device licensing and applicable regulatory requirements.
- MDR 2017 Support: Assistance with classification, registration, licensing, and compliance.
- QMS Implementation: Support for establishing ISO 13485-compliant quality management systems.
- Manufacturing Setup: Regulatory guidance for setting up compliant medical device manufacturing facilities.
- Regulatory Strategy: Helping manufacturers prepare for changing requirements and streamline approvals.
Operon Strategist supports medical device manufacturers in achieving regulatory compliance and market readiness in India.
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FAQ's
What is a Medical Device Park?
A dedicated zone with shared infrastructure for medical device manufacturing.
What are the benefits?
Lower cost, faster setup, shared facilities, and easier compliance.
Is CDSCO approval required?
Yes, it is mandatory for manufacturing and selling medical devices in India.
Which are the top parks?
AMTZ, Telangana, Tamil Nadu, and YEIDA are leading parks.
Which are the top parks?
AMTZ, Telangana, Tamil Nadu, and YEIDA are leading parks.