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Medical Device Registration

CDSCO registration for medical devices across all risk classes (A, B, C, D) for manufacturers and importers in India.

Import RequirementsManufacturing Requirements

Introduction

Medical Device Registration in India is the mandatory process through which manufacturers and importers obtain approval from the Central Drugs Standard Control Organisation (CDSCO) to legally market medical devices in the country.

Under the Medical Devices Rules, 2017 (as amended), all medical devices must be registered or licensed before they can be manufactured, imported, sold, or distributed in India. The rules categorise devices into four risk-based classes: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).

This service is relevant for domestic manufacturers, foreign manufacturers exporting to India, authorised Indian agents, importers, and marketing companies seeking to place medical devices on the Indian market.

Why This Service is Legally Required

Registration is legally mandatory under the Medical Devices Rules, 2017 and the Drugs and Cosmetics Act, 1940. Without a valid registration or license, medical devices cannot be legally manufactured, imported, sold, or distributed in India.
Non-compliance can result in penalties including product seizure, suspension of operations, criminal prosecution, and monetary fines as prescribed under the Act.
Registration also ensures that devices meet safety and performance standards, protecting public health and building trust with healthcare providers and patients.

Applicable Acts, Rules & Regulations

Primary Legislation

  • Drugs and Cosmetics Act, 1940
  • Medical Devices Rules, 2017 (as amended in 2020 and 2022)
  • Drugs and Cosmetics Rules, 1945 (applicable provisions)

Supporting Guidelines & Standards

  • CDSCO Guidance Documents for Medical Devices
  • Indian Medical Device Industry Standards (BIS standards where applicable)
  • ICMR guidelines for clinical investigation of medical devices
  • Relevant ISO standards (ISO 13485, ISO 14971, IEC 60601 series, etc.)

Governing Authorities and Departments

  • Central Drugs Standard Control Organisation (CDSCO) – the primary regulatory authority under the Ministry of Health and Family Welfare, Government of India.
  • Drugs Controller General of India (DCGI) – the head of CDSCO who grants registration and import licenses for medical devices.
  • State Drug Licensing Authorities – for manufacturing licenses at the state level.

Scope of This Service / Registration

All medical devices intended for use in diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury.
Devices sold or distributed in India, whether manufactured domestically or imported.
Applicable to manufacturers (Indian and foreign), importers, authorised agents, and marketing authorisation holders.

Product / Service Classification

Class A (Low Risk) – e.g., tongue depressors, examination gloves, bandages. Registered through CDSCO online portal.

Class B (Low-Moderate Risk) – e.g., hypodermic needles, suction equipment, powered wheelchairs. Require registration certificate from CDSCO.

Class C (Moderate-High Risk) – e.g., haemodialysis equipment, implantable plates, bone cement. Require registration certificate with clinical evidence review.

Class D (High Risk) – e.g., heart valves, pacemakers, drug-eluting stents. Require most rigorous assessment including clinical data and quality system audit.

Import-Related Requirements

Appointment of an Authorised Indian Agent by the foreign manufacturer.
Import Registration Certificate from CDSCO in the name of the importer/authorised agent.
Applicable forms: MD-14 (application for import registration), MD-15 (import registration certificate).
Wholesale drug licence (Form 20B/21B) for the Indian importer.
Free Sale Certificate (FSC) or Certificate of Conformity from the country of origin.
Product-specific technical documentation including device description, intended use, risk analysis, and performance data.
Labelling as per Indian requirements (Medical Devices Rules and Legal Metrology Act).

Manufacturing-Related Requirements

Manufacturing License from the State Drug Licensing Authority.
Site compliance with Good Manufacturing Practices (GMP) as per the Fifth Schedule of the Medical Devices Rules.
Quality Management System compliant with ISO 13485 or equivalent.
Applicable forms: MD-3 (application for manufacturing license), MD-5 (manufacturing license for Class A and B), MD-7 (manufacturing license for Class C and D).
Plant Master File and technical documentation for each device.
State-level inspection and approval prior to license issuance.

Licenses and Approvals Involved

  • Registration Certificate (Form MD-15 for import, Form MD-5/MD-7 for manufacturing)
  • Manufacturing License (Form MD-3 application, Form MD-5 or MD-7 grant)
  • Import License / Registration (Form MD-14 application, Form MD-15 grant)
  • Wholesale License (Form 20B/21B for sale and distribution)
  • Clinical Investigation Permission (Form MD-24, if applicable)
  • Test License (Form MD-9, if applicable)

Documents Required

1Duly filled application form (MD-3 for manufacturing, MD-14 for import)
2Device Master File / Technical Documentation
3Risk analysis report (ISO 14971)
4Essential Principles checklist (Second Schedule compliance)
5Declaration of Conformity
6Quality Management System certificate (ISO 13485)
7Clinical evidence / clinical evaluation report
8Labelling and Instructions for Use (IFU)
9Free Sale Certificate / Certificate of Conformity (for imports)
10Authorised Indian Agent appointment letter (for imports)
11Manufacturing site details and Plant Master File
12Performance evaluation reports / test reports from accredited labs
13Product photographs and packaging details

Step-by-Step Registration Process

1

Regulatory Assessment

Determine device classification, applicable regulatory pathway, and documentation requirements.

2

Documentation Preparation

Compile technical documentation, clinical evidence, quality system certificates, and labelling as per CDSCO requirements.

3

Online Application Submission

Submit the application through the CDSCO Online Medical Device Portal (https://cdscoonline.gov.in) with all supporting documents.

4

Fee Payment

Pay the prescribed government fee online through the CDSCO portal. Fees vary by device class and type of application.

5

CDSCO Review and Query Handling

CDSCO reviews the application and may raise queries. Respond to all technical and administrative queries within the stipulated time.

6

Expert Committee Review (if applicable)

For Class C and D devices, the application may be referred to the Medical Device Technical Advisory Committee for review.

7

Registration Certificate Issuance

Upon satisfactory review, CDSCO issues the Registration Certificate (Form MD-15 for import or MD-5/MD-7 for manufacturing).

Regulatory Timelines

Indicative processing timelines: Class A devices: 1-3 months; Class B devices: 3-6 months; Class C devices: 6-9 months; Class D devices: 9-18 months. Actual timelines depend on completeness of documentation, CDSCO workload, and query resolution speed. These are indicative and subject to variation.

ℹ️ Timelines are indicative and subject to change based on regulatory authority workload and documentation completeness.

Government Fees

  • MD 1 - Certificate of Registration (NotifiedBody): INR 25,000
  • MD 3/5 - License to Manufacture Class A or B: INR 5,000 (plant), INR 400 (per product)
  • MD 6/8 - Loan License to Manufacture Class A or B: INR 5,000 (plant), INR 400 (per product)
  • MD 7/9 - License to Manufacture Class C or D: INR 50,000 (plant), INR 1,000 (per product)
  • MD 10 - Loan License to Manufacture Class C or D: INR 50,000 (plant), INR 1,000 (per product)
  • MD 11 - Audit/Inspection Book Maintenance: INR 5,600
  • MD 12 - License for Clinical Investigation/Test/Evaluation/Training: INR 500/-
  • MD 14 - Import License Class A (non-IVD): INR 1,000 (plant), INR 50 (per product)
  • MD 14 - Import License Class B (non-IVD): INR 2,000 (plant), INR 1,000 (per product)
  • MD 14 - Import License Class C or D (non-IVD): INR 3,000 (plant), INR 1,500 (per product)
  • MD 14 - Import License Class A or B (IVD): INR 1,000 (plant), INR 10 (per product)
  • MD 14 - Import License Class C or D (IVD): INR 3,000 (plant), INR 500 (per product)
  • MD 16 - Import License for Clinical Investigation/Test/Evaluation/Training: INR 100
  • MD 18 - License for Import by Government Hospital/Institution: INR 500/-
  • MD 20 - Permission for Import Small Quantity (Personal use): No Fee
  • MD 22 - Permission for Clinical Investigation: INR 1,20,000
  • MD 24 - Permission for Clinical Performance Evaluation (In Vitro): INR 25,000/-
  • MD 26 - Permission for Import/Manufacture (Non-preclinical devices): INR 50,000/-
  • MD 28 - Permission for Import/Manufacture New In Vitro Diagnostic Device: INR 25,000/-
  • MD 30 - Registration for Medical Device Testing Laboratory: INR 20,000/-

ℹ️ Fees are subject to revision by the respective government authorities.

Common Challenges & Compliance Risks

Incorrect device classification leading to wrong regulatory pathway and delays.
Incomplete or non-compliant technical documentation causing CDSCO queries.
Mismatch between manufacturing license scope and product registration.
Labelling non-compliance with Indian requirements (e.g., missing Legal Metrology declarations).
Delays in clinical evidence compilation or inadequate clinical data for Class C/D devices.
Portal-related issues during online submission or fee payment.
Missed renewal deadlines leading to lapsed registrations.

How Globallex Compliance Helps

Comprehensive regulatory assessment to determine the correct device classification and pathway.
End-to-end documentation support including Device Master File, clinical evaluation, and risk analysis.
Application preparation and filing through the CDSCO online portal.
Query management and liaison with CDSCO officials for timely resolution.
Post-registration compliance support including renewals, amendments, and vigilance reporting.
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Disclaimer: The information provided on this page is for general informational purposes only and does not constitute legal advice. Regulations, fees, and procedures are subject to change. Please consult with Globallex Compliance for the latest regulatory position and personalized guidance.