1. Certification Overview
The Indian CDSCO classifies medical devices into a total of four classes, from A to D, based on their risk level.
Medical devices falling under these categories must apply for online registration and obtain a license upon import into India, in accordance with the Indian Medicines and Cosmetics Regulations.
For Class A and B medical devices, applications and certificate issuance can be performed using MD1 and MD2 forms, and this process can be carried out at designated institutions appointed by national certification bodies.
For Class C and D medical devices, applications are submitted via the Sugam online portal using forms MD7 and MD8, followed by applications using forms MD9 and MD10, after which approval is issued using forms MD9 and MD10.
2. Regulatory Bodies & Basic Information
| Regulatory Agencies | CDSCO (Central Drugs Standard Control Organization) |
| Certification (Registration) Authority | Class A, B Medical Device: 1. UL India 2. Intertek India 3. TUV Rheinland India |
| Testing Agency | 1. BEE PHARMOLABS 2. QVC Certification services 3. Sipra Labs |
| Language | English |
| Agent | An India Authorized Agent (IAA) is required |
List of CDSCO-registered Notified Bodies
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class A | Low risk | • Manual Orthopedic & Mobility Aids: Manual wheelchairs, Walking aids, Crutches • Non-invasive Examination Tools: Mechanical stethoscopes, Tongue depressors, Medical beds • Consumables & Dressings: Elastic bandages, Surgical drapes, Non-sterile examination gloves |  Crutches |
| Class B | Low to Moderate Risk | • Basic Electronic Diagnostic Equipment: Digital thermometers, Electronic sphygmomanometers (Blood pressure monitors), ECG monitors • Non-high-risk Invasive Devices: Hypodermic needles, Suction equipment, Disposable syringes • Surgical Wear & Protective Gear: Sterile surgical gloves, Surgical gowns, Personal protective equipment |  Disposable syringes |
| Class C | Moderate to High Risk | • Critical Life-Support & Therapy Systems: Infusion pumps, Mechanical ventilators, Dialysis machines • Active Imaging & Diagnostic Systems: X-ray systems, MRI machines, Ultrasound imaging equipment • Non-cardiovascular Fixation Implants: Bone fixation plates/screws, Orthopedic implants, Intraocular lenses |  MRI machines |
| Class D | High Risk | • Central Circulatory & Cardiac Implants: Implantable pacemakers, Heart valves, Drug-eluting stents • Advanced Life-Sustaining Systems: Ventricular assist devices (VAD), Intra-aortic balloon pumps (IABP) |  Implantable pacemakers |
Risk Classification of Medical Devices under the MDR, 2017
4. Certification Process
- Access the registration link: https://cdscomdonline.gov.in/NewMedDev/Homepage
- Registration
- Register a valid email address and mobile phone number
- Upload documents
- ID card, pledge, certificate of incorporation, manufacturing license, and wholesale license, etc.
- OTP authentication
- Login and Registration
5. Required Documents
| Administrative Information | • Local Rep & Importer Info: Name and business qualification information of the local company or other legal entity importing the medical device (wholesale license required). • Certificate of Free Sale (CFS): A government-issued document proving that the medical device is being legally sold in its country of manufacture (country of origin). • Declaration / Undertaking: An official declaration guaranteeing the authenticity of the product information and submitted documents. |
| Device Description & Specifications | • Medical Device Details (Device Master File – DMF Requirements): A document specifying the technical elements of the product in detail 1) Generic Name 2) Model Number 3) Intended Use 4) Risk Classification (Class A~D) 5) Material of Construction 6) Dimensions 7) Brand Name |
| Labeling & Packaging | • English Labeling & Packaging Specifications (English Labeling & IFU): Sample English label and instruction manual reflecting the details in Item 2 above (brand name, model name, sterility status, expiration date, etc.) • Import/Maintenance Information (Shelf-Life & Sterility Statement): Verification data for the mandatory information 7) Shelf-life and 8) Sterility status. |
| Quality Management System | • ISO 13485 Certificate of Conformity: Quality Management System certificate for overseas manufacturing facilities. It must be the latest version issued by a certification body accredited by the NABCB (National Accreditation Board of India) or the IAF (International Accreditation Forum) (management of validity period is essential). |
| Standards & Compliance | • Product Standards & Specifications: List of international standards (ISO, IEC, etc.) or local Indian standards (BIS) complied with by the medical device, and summary of conformity verification reports. |
6. Validity Period and Maintenance
- Validity Period: 5 years
Source
Online System for Medical Devices Homepage
CDSCO Homepage