Medical Devices Certification

We provide comprehensive support for Medical Device certification in India, ensuring compliance with CDSCO regulations for Class A, B, C & D medical devices.

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Introduction to Medical Device Regulation

Medical devices have always been a major area of concern and regulation for the Indian Government. With the advancement of medical technology and the exponentially growing demand for medical devices in India, new regulatory reforms have been introduced to ensure quality, safety, and compliance.

The Medical Devices Rules, 2017 (MDR), govern the certification, import, and manufacture of medical devices in India and are enforced by the respective Central and State Licensing Authorities.

Classification and Risk Categories

Medical devices are classified into four categories based on their associated risk levels

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Class A

Low Risk

Examples:

  • • Thermometers
  • • Surgical dressings
  • • Umbilical tapes
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Class B

Low-Moderate Risk

Examples:

  • • Nebulizers
  • • Digital thermometers
  • • Blood pressure monitors
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Class C

Moderate-High Risk

Examples:

  • • Catheters
  • • Orthopedic implants
  • • Cardiac stents
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Class D

High Risk

Examples:

  • • Heart valves
  • • Pacemakers
  • • Defibrillators

Note: Devices are further categorised as surgical or non-surgical depending on their invasiveness. Higher-risk devices (Class C & D) require more stringent certification procedures than lower-risk ones.

Mandatory CDSCO Approval

All medical devices and IVD devices require approval from the appropriate licensing authority

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State Licensing Authority (SLA)

Handles manufacturing licenses for lower-risk devices:

  • • Class A device manufacturing
  • • Class B device manufacturing
  • • State-level regulatory oversight
  • • Simplified approval process
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Central Licensing Authority (CLA)

Handles high-risk devices and all imports:

  • • Class C & D device manufacturing
  • • All import-related approvals (Class A-D)
  • • Central-level regulatory oversight
  • • Stringent approval process
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Role of the SUGAM Portal

The SUGAM portal, introduced by CDSCO, has simplified and digitised the end-to-end licensing process, making it easier and faster for manufacturers and importers to obtain necessary approvals.

Medical Devices Notified Under Regulation

37 categories of medical devices currently under CDSCO regulation

Disposable Hypodermic Syringes
Disposable Hypodermic Needles
Disposable Perfusion Sets
In Vitro Diagnostic Kits for HIV, HBsAg & HCV
Cardiac Stents
Drug-Eluting Stents
Catheters
Intraocular Lenses
I.V. Cannulae
Bone Cements
Heart Valves
Scalp Vein Set
Orthopedic Implants
Internal Prosthetic Replacements
Ablation Devices
Blood Grouping Sera and Substances
Ligatures, Sutures, and Staplers
Intrauterine Devices (Cu-T)
Condoms
Tubal Rings
Surgical Dressings
Umbilical Tapes
Blood / Blood Component Bags
Disinfectants
Nebulizers
Blood Pressure Monitoring Devices
Digital Thermometers
Glucometers
All Implantable Medical Devices
MRI Equipment
CT Scan Equipment
Dialysis Machines
PET Equipment
X-Ray Machines
Defibrillators
Bone Marrow Cell Separators
Ultrasound Equipment

Certificate Types & Applicable Authorities

Authority requirements based on device class and activity type

Device Class / ActivityClass AClass BClass CClass D
ImportCLACLACLACLA
ManufactureSLASLACLACLA
Clinical Investigation-Permission from CLA--
QMS VerificationNotified Body (CLA)Notified Body (CLA)CLACLA

Applicable Forms & Their Purpose

12 different forms for various medical device applications

Form No.Application Type
MD-3Application for license to manufacture Class A or Class B devices
MD-4Application for loan license to manufacture Class A or Class B devices
MD-5License to manufacture Class A or Class B medical devices
MD-6Loan license to manufacture Class A or Class B medical devices
MD-7Application for license to manufacture Class C or Class D devices
MD-8Application for loan license to manufacture Class C or Class D devices
MD-9License to manufacture Class C or Class D medical devices
MD-10Loan license to manufacture Class C or Class D medical devices
MD-14Application for import license to import medical devices
MD-15License to import medical devices
MD-41Application for registration certificate to sell, stock, exhibit or offer for sale
MD-42Registration certificate to sell, stock, exhibit or offer for sale
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Importing Medical Devices

Foreign manufacturers must appoint an Authorised Indian Representative (AIR) to apply for the license.

Application submission via SUGAM portal
Filing Form MD-14 with required documents
Post-inspection, Import License issued in Form MD-15
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Manufacturing Medical Devices

For Class A & B Devices:

  • • Apply using Form MD-3 to State Licensing Authority (SLA)
  • • Post-inspection approval under Form MD-5

For Class C & D Devices:

  • • Apply using Form MD-7 to Central Licensing Authority (CLA)
  • • Post-inspection approval under Form MD-9

Application Process Overview

6-step general procedure for medical device licensing

1

Applicant Registration

Register on SUGAM Portal

2

Draft Filing

Draft filing of the application

3

Document Upload

Upload required documents

4

Review & Inspection

Authority review and inspection

5

Fee Payment

Government fee payment

6

License Issuance

Submission and license issuance

Important Points

Safety Obligation: If a manufacturer or authorized agent considers that a medical device which has been imported, manufactured, sold, or distributed is likely to be unsafe, they shall immediately initiate the procedure to withdraw the medical device from the market and inform the competent authority without delay.

Registration Requirement: The medical device must be registered with the Central Licensing Authority through the designated online portal established by CDSCO. A registration number will be generated and must be mentioned on the device label.

Frequently Asked Questions

Everything you need to know about our platform

The higher the risk class (Class C & D), the more rigorous the evaluation, including clinical data, Quality Management System (QMS) audits, and Notified Body involvement. Class A devices may be self-certified, while Class D may require extensive testing, overseas inspection reports, and longer processing timelines by CDSCO.

Applications may be rejected due to: • Incomplete documentation (e.g., missing Free Sale Certificate, Plant Master File) • Inadequate labeling as per MDR • Lack of evidence for safety/performance • Mismatch between device classification and claimed intended use • Improper appointment of Authorised Indian Representative (AIR) without a valid Power of Attorney

For Class B, C, and D devices, compliance with ISO 13485 is often mandatory. CDSCO may require QMS verification through a Notified Body audit for manufacturing licenses. Lack of QMS certification or gaps in the audit report can delay or deny approval.

Any change in the intended use, composition, labeling, or design must be notified to CDSCO. A variation application must be filed with supporting documents. CDSCO may decide whether a fresh application is needed or if an amendment to the existing license suffices.

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