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, and registration is mandatory for all notified devices. This 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 ensure that only certified and reliable devices reach hospitals, clinics, and patients. This process also aligns Indian regulations 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, and 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.
Example: This definition covers a wide range of healthcare products such as surgical dressings, sutures, blood bags, contraceptive devices like condoms and copper-T, disinfectants, insecticides, diagnostic tools like glucose test strips and pregnancy kits, and medical equipment such as X-ray machines, ECG monitors, ventilators, and insulin pens when notified by the government. All these products are regulated to ensure safety, effectiveness, and quality before being used or sold in India.
Is there any classification criteria for medical devices, and into how many classes are medical devices categorized?
As per Part I of the First Schedule of MDR-2017, medical devices are classified based on the level of risk they pose to the patient or user. This classification helps determine the extent of regulatory scrutiny and safety requirements a device must meet before being placed on the market.
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)
Higher-risk medical devices require more rigorous evaluation and regulatory controls. This classification system ensures patient safety by aligning regulatory requirements with the potential risk associated with the device’s intended use.
What is the timeline for the grant of import licenses for medical devices?
As per the Medical Devices Rules, 2017, if the application is complete in all respects and complies with the prescribed requirements, the Central Licensing Authority (CDSCO) shall grant the import license (Form MD-15) within 9 months from the date of application.
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
Confirm whether the device is notified under CDSCO. Only notified medical devices require registration.
Step 3: Appoint Authorized Indian Agent (for Foreign Manufacturer)
For foreign manufacturers, appoint an authorized agent in India 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 via CDSCO Portal:
Submit Form MD-14 (for import) or MD-3 (for domestic manufacturers)
Step 6: Pay Fees
Pay the applicable registration fee as per the device class.
Step 7:Evaluation by CDSCO
CDSCO reviews the application and may raise queries or request clarifications.
Step 8: Grant of Registration
If all documents are in order, CDSCO issues a Registration Certificate (Form MD-15 or MD-5).
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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