Comparision between India EU and US Regulatory Requirements
This comparison sheet outlines the regulatory requirements and differences between the three countries – EU, India, and the US – required for medical device submissions.
With the increasing globalization of healthcare technology, understanding and complying with region-specific medical device regulations is critical for manufacturers aiming to access international markets. Each jurisdiction follows a distinct regulatory framework with varying levels of scrutiny, classification systems, conformity assessment procedures, and post-market surveillance obligations.
While the EU emphasizes a harmonized, risk-based approach under the Medical Device Regulation (MDR), the US FDA adopts a predicate-based clearance model, and India is rapidly evolving its regulatory ecosystem under CDSCO's Medical Device Rules. This comparison aims to provide manufacturers, importers, and regulatory professionals with a concise understanding of the similarities, divergences, and strategic considerations necessary for successful submissions in these key regions.
Comparison Table 1
Requirements
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INDIA
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EU
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US
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Classification
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Class A, B, C, and D
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Class I, IIa, IIb, and III
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Class I, II, and III
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Regulatory Bodies
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CDSCO
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European Commissions
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US FDA
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Registration portal
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Sugam Portal & NSWS Portal
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EUDAMED & Local Competent Authority by Authorised Representative
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FURLS
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Type of Agents Required for Foreign Companies
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Authorised Indian Agent
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European Authorised Representative
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US Agent
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Where to find predicates?
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CDSCO Approved Lists & CDSCO Public Notices
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EUDAMED database
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FDA's product classification database, such as the 510(k) database
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Notified Body Audits
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Yes
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Yes
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Not Applicable. Self-declaration is accepted
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Comparison Table 2
Requirements
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INDIA
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EU
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US
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Quality Management System Requirement
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ISO 13485:2016
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EN ISO 13485:2016
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21 CFR Part 820 (being aligned to ISO 13485)
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Labelling Requirements
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Comply with Medical Device Rules (MDR) 2017 - including UDI, manufacturing, expiry, etc
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Include UDI, CE mark, EC REP info, language requirements, per MDR Annex I, Chapter III
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Comply with 21 CFR part 801 (includes UDI, Intended Use, Manufacturer, Warnings)
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UDI Required?
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Yes
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Yes
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Yes
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Post-market Surveillance (PMS) Requirement
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Required for all classes
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Required for all classes
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Required for class II and higher devices
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Usability Engineering
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Not explicitly required under Indian MDR, but considered under risk management and IEC 62366 in practice
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Required as per Annex I (General Safety & Performance Requirements) in MDR and IEC 62366
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Recommended under FDA guidance. Also known as Human Factor Validation.
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Foreign Clinical Data
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Accepted. For high-risk devices, clinical studies may be required locally
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Accepted. For high-risk devices, clinical studies may be required locally
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Accepted. For high-risk devices, clinical studies may be required locally
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