As per the  Drugs and Cosmetics Act, 1940 the Definition of Medical device is  “Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.”

Class A

Represents the low-risk category of the products such as thermometers and tongue Depressors.

Examples: Tongue depressors, Bandages, Non-powered wheelchairs, surgical gloves.

Class B

Represents moderate-risk products such as suction equipment and hypodermic needle.

Examples: Hypodermic needles, Thermometers, Blood pressure monitors, Stethoscopes.

Class C

Represents moderate-high risk products such as bone fixation and lung ventilator.

Examples: Syringes, Surgical drapes, orthopedic implants, Heart valves.

Class D

Represents high-risk products such as implantable devices and heart valve.

Examples: Implantable pacemakers, Cardiac stents, Artificial heart valves, ventilators, Dialysis machines.

The regulatory body responsible for approving applications and authorizing the importation of medical devices into India is the Central Drug Control Organization (CDSCO).

To import medical devices that have been notified, it is necessary to obtain an import license called Form MD-15 from the CDSCO, in accordance with the Medical Devices Rule of 2017.

To import notified medical devices, both the manufacturing site and the medical devices themselves must be registered with the CDSCO.

The process of obtaining a Medical Device import license involves filling out Form MD-14 and submitting it to the CDSCO Medical Device Department

It is important to note that an authorized Indian agent must be appointed for this purpose. The appointed agent should possess a license to manufacture (for sale or distribution) or a license to wholesale (sale or distribution) medical devices, as per the applicable rules.

The agent will then initiate the application process for the import license by submitting the necessary documents through the Sugam online portal. This portal serves as a platform for applying and managing various regulatory processes related to medical devices in India.

Step1- Evaluation of the product, whether it falls under the regulated or non-regulated category, is a crucial step in the registration process as per the Medical Devices Rules (MDR) of 2017

Step2- If the product requires registration, it undergoes evaluation to determine its classification (Class A, B, C, or D) based on the level of risk associated with the product

Step3- Documents are prepared following the MD-14 checklist, adhering to the requirements of the Medical Devices Rule (MDR) in India.

Step 4– Appoint an Authorized Indian Agent

Step 5- The application is generated online, utilizing the prescribed format specified by the regulatory authority, for the submission of the registration documents

Step 6- The draft application is reviewed and approved by the authorized agent before the final submission to the regulatory authority for further processing and evaluation as per the Medical Devices Rule (MDR) in India

Step 7- Maintain proactive communication with the regulatory authority, addressing any queries that arise during the approval process

Step 8- Obtain the approval for importing medical devices in India through the necessary regulatory processes and compliance with applicable regulations

The registration process, the necessary documents for obtaining the medical device import license in India are prepared in accordance with the MD-14 checklist

• Form 14
• Wholesale License
• Power of Attorney
• Free Sale Certificate
• GHTF Device Master File
• Site Master File
• Full Quality Assurance Certificate
• CE Design Certificate
• Fee Challan (TR6 Challan)

The fee structure for obtaining an import license for medical devices is based on the risk classification of the devices. The fees are as follows:

For Class A medical devices (excluding in vitro diagnostic devices), the import license fee is USD 1000 for one manufacturing site. Additionally, there is a cost of USD 50 for each distinct medical device.

For Class B medical devices (excluding in vitro diagnostic devices), the import license fee is USD 2000 for one manufacturing site. Each distinct medical device incurs a cost of is USD 1000.

For Class C or Class D medical devices (excluding in vitro diagnostic devices), the import license fee is USD 3000  for one manufacturing site. Each distinct medical device carries a cost of USD 1500 -/-