ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Our medical devices and IVD regulatory consultants bring the right mix of subject matter expertise and industry experience for the smooth launch of your devices / diagnostics in Indian market. Right from Strategy, Registration to Post Market Maintenance as Indian Authorized Representative, Artixio is partner with leading medical devices manufacturers.
Medical Devices
Registration in India
India
The Medical Devices Market in India
Est. US $11 Billion Market Size
Expected to Grow to $50 Billion in 5 years
Current Share of 1.5% in Global Market
75% Import of Medical Devices
Regulatory Authorities in India for Medical Devices
In India, medical device registration is overseen by the Central Drugs Standard Control Organisation (CDSCO), which is part of the Ministry of Health & Family Welfare's Directorate General of Health Services. The CDSCO is India's National Regulatory Authority (NRA).
Medical Devices in India are governed by
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Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
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Medical Devices Rules, 2017
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Medical Devices (Amendment) Rules, 2020
Classification of Medical Devices in India
Medical equipment are categorised into four risk categories: A, B, C, and D. The CDSCO application processing fees are determined by the device categorization. The application process takes 6 to 9 months regardless of device categorization.
Once accepted, each manufacturing site receives an Import Licence, MD Form 15, which lists the allowed products.
Class
Risk
Analysis
Blood presure cuffs, scissors, etc
Minimal risk
Class A
Low to Moderate risk
Class B
Moderate to High risk
Class C
Highest risk
Class D
Implantable devices/devices
Process
Documents Required for Registration of Medical Devices in India
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Form 40
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TR6 Challan
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Power of Attorney
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Schedule D(1)
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ISO 13485 Certificate • Quality Assurance Certificate
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CE Certificate
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Declaration of Conformity
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Free Sale Certificate
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Post Marketing Study Reports
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Plant Master File
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Device Master File
Medical Devices Registration Services in India
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Indian Authorized Representative and Import Services
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Gap Analysis
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Regulatory Intelligence and Strategy
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Consultation and Meeting
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Technical File Preparation and Submission Quality Management System Implementation
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Audit Support
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Quality Training
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Response to Queries
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Clinical Evaluation and Post Marketing Evaluation
Appoint an Indian Authorized Representative (IAR)
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The Indian Authorised Representative (IAR) will be the license holder in India for foreign manufacturers.
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The Authorised Representative will be responsible for post-approval maintenance of the licenses and post-market surveillance.
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The Foreign Manufacturer can act as Authorised Representative if they have their subsidiary in India. Alternatively, their Distributor or Artixio can act as an Indian Authorised Representative on behalf of the manufacturer.
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The technical file in CSDT format is prepared and submitted to MDA by Authorized Representative
Medical Devices Classification as per CDSCO Standards
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IAR will assist in classification of medical devices as per MDR regulations
. Gap Analysis
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Collation of Documents and evaluation and identification of any gaps
Compile Device Master File
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Compilation of the Device Master File and other site related documents
Create SUGAM Account
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IAR will create a SUGAM account on behalf of the foreign manufacturer to upload administrative information and device dossier
Prepare Technical Documentation and Upload to SUGAM
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Upload requisite documents along with applicable fee per device category
Review and Approval by CDSCO
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CDSCO will offer its decision post receiving responses to any queries.
Explore how we can help your MedTech Product launch in India.
Services Offered
Market Size & Landscape Analysis
KOL Analysis
Price Sensitivity Analysis
Distributor Search and Licensing
Market Access
Marketing Authorization Holder
Post Market Maintenance
Post Market Surveillance Query Responses
Authorized Representative
Regulatory Intelligence & Strategy, Gap Analysis, Remediation and Submission
Regulatory Affairs
QMS Implementation
ISO 13845 Consulting, 21 CFR
820, SOP Development, Audits
Quality Management
Clinical evaluation reports (MEDDEV 2.7.1)
Clinical investigation protocols and reports
Medical Writing & Medical Review
Clinical Services
Contact our team
With Our Expert Regulatory Team based at our Regional Office in Malaysia, Artixio can act as your Authorized Representative and help you launch your products successfully in the country from Strategy, Registration to Post Market Support.
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