Medical Device Licensing Timelines in India Set to Shorten Under Proposed MDR 2026 Amendments
India Proposes Faster Medical Device Manufacturing License Approvals
India’s medical device industry could soon benefit from significantly faster manufacturing license approvals. The Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Medical Devices Rules, 2017 through Draft Notification G.S.R. 515(E), published on June 23, 2026.
The proposed changes aim to reduce licensing timelines while maintaining strict quality, safety, and performance standards. The initiative is part of the Government of India’s ongoing efforts to improve the ease of doing business and accelerate the availability of high-quality medical devices in the Indian market.
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Key Changes to Medical Device Licensing Timelines
Under the proposed amendments, manufacturers can expect quicker approval timelines across different medical device risk classes.
| Medical Device Class | Current Timeline | Proposed Timeline |
|---|---|---|
| Class B (Low to Moderate Risk) | 140 Days | 115 Days |
| Class C & D (High Risk) | 105 Days | 90 Days |
These revised timelines are expected to benefit both domestic manufacturers and international companies planning to establish medical device manufacturing operations in India.
Revised Licensing Process for Class B Medical Devices
Class B medical devices, including products such as hypodermic needles, blood pressure monitors, and pulse oximeters, are regulated by the State Licensing Authorities under Rule 20.
The proposed amendments introduce fixed timelines for every stage of the licensing process:
- Application scrutiny and assignment to a Notified Body within 30 days.
- Notified Body audit to be completed within 30 days.
- Audit report and recommendations to be submitted within 15 days after inspection.
- Compliance verification for quality management system deficiencies to be completed within 20 days after receiving the manufacturer’s response.
These defined timelines are intended to make the licensing process more transparent and predictable.
Faster Review Process for Class C and Class D Medical Devices
Higher-risk medical devices such as cardiac stents, orthopedic implants, and other critical products are licensed centrally by CDSCO under Rule 23.
The proposed amendments include:
- Reduction of one inspection stage from 60 days to 55 days.
- Introduction of a new 15-day compliance verification period for inspection observations.
- Reduction of two additional review timelines from 45 days to 30 days and from 45 days to 20 days.
Another notable proposal is the introduction of a “deficiency clock.” If regulators identify deficiencies during the review process, the approval timeline will pause and restart only after the manufacturer submits satisfactory corrective actions. This creates greater clarity for both regulators and manufacturers.
What About Class A Medical Devices?
Class A medical devices remain largely unaffected by the proposed amendments.
Following the 2020 amendments to the Medical Devices Rules, non-sterile and non-measuring Class A devices can be registered through CDSCO’s Sugam Portal using a simplified self-registration process instead of obtaining a manufacturing license.
However, sterile or measuring Class A devices still require a manufacturing license before they can be manufactured or marketed in India.
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How India's Regulatory Framework Compares with FDA and EU MDR
India follows a four-tier risk classification system (Class A to Class D), based on internationally accepted risk-based principles.
United States (FDA)
The U.S. FDA classifies devices into three categories:
- Class I
- Class II
- Class III
Most moderate-risk devices are reviewed through the FDA 510(k) pathway, while high-risk devices require Premarket Approval (PMA), which generally involves a longer review process.
European Union (EU MDR)
Unlike India and the United States, the European Union does not have a centralized approval authority for medical devices.
Manufacturers obtain CE Marking through independent Notified Bodies under the Medical Device Regulation (EU) 2017/745. Certification timelines often vary depending on the workload and availability of individual Notified Bodies.
India's Competitive Advantage
The proposed statutory timelines make India’s licensing process more predictable compared to many international regulatory systems.
For global manufacturers evaluating new markets, India is becoming an increasingly attractive destination due to:
- Clearly defined approval timelines
- Risk-based regulatory framework
- Growing manufacturing ecosystem
- Government support for medical device innovation
- Improved ease of doing business
Evolution of India's Medical Device Regulatory System
Before the Medical Devices Rules, 2017 came into force, medical devices in India were regulated under the Drugs and Cosmetics Act, 1940.
The introduction of MDR 2017 established India’s first dedicated regulatory framework for medical devices based on product risk classification.
Subsequent amendments expanded regulatory coverage, bringing all medical devices under CDSCO regulation. By October 2023, licensing requirements had become mandatory for Class C and Class D devices.
The proposed 2026 amendments continue this modernization effort by focusing on faster approvals without compromising regulatory oversight.
Government's Broader Regulatory Reform Initiative
The proposed licensing reforms align with the Government of India’s “Minimum Government, Maximum Governance” initiative.
Recent regulatory reforms have focused on:
- Simplifying compliance procedures
- Digitizing regulatory processes
- Replacing imprisonment for minor technical violations with civil penalties
- Improving transparency for manufacturers
- Encouraging domestic medical device manufacturing
These reforms are expected to strengthen India’s position as a global medical device manufacturing hub.
What These Changes Mean for Medical Device Manufacturers
If implemented, the proposed amendments will help manufacturers:
- Launch products faster
- Reduce regulatory waiting periods
- Improve production planning
- Accelerate market entry
- Increase investor confidence
- Enhance overall regulatory predictability
Companies planning to manufacture medical devices in India should begin preparing their Quality Management Systems (QMS), technical documentation, and regulatory submissions to take advantage of the streamlined approval process.
How Operon Strategist Can Help
Navigating India’s evolving medical device regulations requires regulatory expertise and thorough documentation. Operon Strategist provides end-to-end consulting services to help manufacturers achieve faster approvals while ensuring full compliance with CDSCO requirements.
Our services include:
- CDSCO Medical Device Registration
- Medical Device Manufacturing License Support
- Medical Device Classification
- Technical Documentation Preparation
- ISO 13485 Implementation
- Quality Management System (QMS) Consulting
- Plant Setup and Turnkey Manufacturing Projects
- Regulatory Strategy and Gap Assessment
- Clinical Evaluation and Risk Management Documentation
- Global Regulatory Support including FDA 510(k), CE Marking, UKCA, MDSAP, and other international approvals
Whether you are a startup or an established medical device manufacturer, Operon Strategist helps simplify complex regulatory processes and supports successful market entry in India and global markets.
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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.