What is CDSCO Medical Device Registration?
CDSCO medical device registration is the process of getting approval from the Central Drugs Standard Control Organization to sell or import medical devices in India. This ensures that the device is safe and meets Indian regulations. Medical devices are divided into different classes. The registration is mandatory for all notified devices. This registration process was introduced to ensure the safety, quality, and performance of medical devices sold or imported in India. Earlier, most medical devices were not regulated, which posed risks to patient health and safety. With the growing use of advanced medical technologies, the Government of India implemented a structured regulatory framework through the Medical Devices Rules, 2017. The aim was to make sure that only certified and reliable devices reach hospitals, clinics, and patients. This process also brings Indian regulations in line with global standards and helps monitor and control unsafe or substandard devices.
What is meant by a medical device?
As per Rule 3(zb) of the Medical Devices Rules, 2017, a "medical device" means:
- Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bags with or without anticoagulant;
- Substances including mechanical contraceptives such as condoms, intrauterine devices, tubal rings; disinfectants; and insecticides;
- Devices notified from time to time as medical devices by the Central Government.
Explanation: For the purposes of these rules, substances used for in vitro diagnosis shall be referred to as in vitro diagnostic medical devices.
Who is mandatorily required to obtain this registration?
As per the regulatory framework, the following entities are mandatorily required to obtain CDSCO registration for the import of cosmetics into India:
- The manufacturer himself
- The authorized agent of the manufacturer in India
- The subsidiary of the manufacturer
- Any other importer
Any of these parties may apply for the Registration Certificate. However, no cosmetic product can be legally imported into India without this registration, as mandated under the Cosmetics Rules, 2020.
Is there any classification criteria for medical devices, and how many classes exist?
As per Part I of the First Schedule of MDR-2017, medical devices are classified based on the level of risk they pose to patients or users. This risk-based classification helps define the necessary safety measures and regulatory scrutiny required for market approval.
Medical Device Classification:
- ✔️ Class A – Low risk (e.g., thermometers, stethoscopes)
- ✔️ Class B – Low to moderate risk (e.g., infusion pumps, hypodermic needles)
- ✔️ Class C – Moderate to high risk (e.g., ventilators, bone fixation plates)
- ✔️ Class D – High risk (e.g., heart valves, implantable defibrillators)
Devices with higher risk (Class C and D) undergo stricter regulatory control and performance assessment. This structured classification ensures patient safety by aligning compliance measures with the device’s intended use and potential harm.
What is the validity of the import license granted in Form MD-15?
The import license (Form MD-15) is valid indefinitely unless suspended or cancelled by CDSCO. However, the license holder must pay a retention fee every 5 years from the date of issue. Failure to pay the fee may result in cancellation of the license.
What is the Registration fee of Medical device in case of import?
The registration fee for medical devices in case of import is specified under the Second Schedule of the Medical Devices Rules, 2017, and varies according to the class (risk category) of the device.
What is the registration process for medical devices?
Registration Process for Medical Devices in India (under CDSCO):
Step 1: Determine Classification
Identify the device class (A, B, C, or D) based on risk level under the Medical Devices Rules, 2017.
Step 2: Check Notification Status
Ensure the medical device is notified under CDSCO. Only notified devices need registration.
Step 3: Appoint Authorized Indian Agent (for Foreign Manufacturer)
Foreign manufacturers must appoint an authorized Indian representative (AIR) to act on their behalf.
Step 4: Prepare Documents
Collect DMF, PMF, ISO certificate, Free Sale Certificate, clinical data (if required), and other relevant documents.
Step 5: Apply on CDSCO Portal
Use Form MD-14 for imports or MD-3 for domestic manufacturers. Submit the application through the official CDSCO portal.
Step 6: Pay Registration Fees
Pay applicable fees based on the classification of the device as per CDSCO’s fee schedule.
Step 7: CDSCO Scrutiny
CDSCO reviews your application, evaluates documentation, and may request clarifications.
Step 8: Grant of Registration
Upon successful review, CDSCO issues a Registration Certificate in Form MD-5 (domestic) or MD-15 (imported).
How can we help you?
At BR & Associates, we assist you with end-to-end support for CDSCO medical device registration, including documentation, classification, portal submission, and regulatory liaison. Our expert team ensures smooth processing and compliance with Medical Devices Rules, helping you obtain import licenses or registration certificates efficiently and within the required timelines.
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