CDSCO Medical Device Registration: What You Need to Know

Discover essential insights into CDSCO Medical Device Registration with our comprehensive guide. Gain a clear understanding of the crucial information you need to navigate the registration process effectively. Stay informed, compliant, and prepared for successful medical device registration in India.

The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body in India responsible for the registration of medical devices. The registration process is mandatory for all medical devices that are manufactured, imported, or sold in India.

Types of CDSCO Medical Device Registration

Registration to Manufacture Class A or Class B Medical Devices (MD 5): This type of registration is for manufacturers of Class A or Class B medical devices. Class A devices are low-risk devices, while Class B devices are low-moderate-risk devices.
Registration to Manufacture Class A or Class B Medical Devices on Loan Premises (MD 6): This type of registration is for manufacturers of Class A or Class B medical devices on loan license. A loan premises is a facility that is owned by another company but is being used by the manufacturer to manufacture their medical devices.
Registration to Manufacture Class C or Class D Medical Devices (MD 9): This type of registration is for manufacturers of Class C or Class D medical devices. Class C devices are medium-risk devices, while Class D devices are high-risk devices.
Registration to Manufacture Class C or Class D Medical Devices on Loan Premises (MD 10): This type of registration is for manufacturers of Class C or Class D medical devices on loan license.
Registration for the Purposes of Clinical Investigation or Test or Evaluation of Medical Devices (MD 13): This type of registration is for manufacturers of medical devices who want to conduct clinical investigations or tests or evaluations of their devices.
Registration to Import Medical Devices (MD 15): This type of registration is for importers of medical devices into India.
Registration to Import Medical Devices for the Purposes of Clinical Investigations, Test, or Evaluation (MD 17): This type of registration is for importers of medical devices who want to conduct clinical investigations, tests, or evaluations of their imported devices.
Registration to import medical devices for personal use (MD 21): This type of registration is for individuals who want to import medical devices for their own personal use.
Registration for Permission to Conduct Clinical Investigation (MD 23): This type of registration is for researchers who want to conduct clinical investigations of medical devices.
Registration to conduct a clinical performance evaluation of new in vitro diagnostic medical devices (MD 25): This type of registration is for manufacturers or importers of new in vitro diagnostic medical devices who want to conduct a clinical performance evaluation of their devices.
Registration to import or manufacture for sale or for distribution of medical device that does not have a predicate medical device (MD 27): This type of registration is for manufacturers or importers of medical devices that do not have a predicate medical device. A predicate medical device is a medical device that is already approved for sale or distribution in India.
Registration to Import or Manufacture New In-Vitro Diagnostic Medical Device (MD 29): This type of registration is for importers of new in vitro diagnostic medical devices.
Registration to sell, stock, exhibit, or offer for sale or distribute a medical device including In-Vitro diagnostic device (MD 42): This type of registration is for businesses that want to sell, stock, exhibit, or offer for sale or distribute medical devices, including in vitro diagnostic devices.

Risk Based Classification of Medical Devices in India

Medical devices in India are classified into four classes based on their risk level:

Class A: Low-risk devices approved by the State Licensing Authority
Class B: Low to moderate-risk devices approved by the State Licensing Authority
Class C: Moderate to high risk approved by CDSCO
Class D: High-risk devices approved by CDSCO

Medical devices classified as Class A and B are considered low- and moderate-risk, respectively. The State Licensing Authority is responsible for approving Class A and B devices.

Classes C and D Devices are categorized as Moderate to High Risk, respectively. CDSCO is the Licensing Authority for Class C and D devises.

Documents Required for CDSCO Medical Device Registration

Power of Attorney
Valid copy of manufacturing license
Free Sale Certificate
Inspection or Audit Report
ISO 13485 Certificate
CE Certificate
CE Design Certificate
Declaration of Conformity
Manufacturing site or establishment registration copy.
Plant Master File
Device Master File

To obtain the CDSCO Medical Device Registration, you need to submit the above documents along with the application copy.

CDSCO Medical Device Registration Process

The CDSCO medical device registration process is a multi-step process that can take several months to complete. The following are the steps involved in the process:

Classification of the medical device: The first step is to classify the medical device into one of four risk classes based on its intended use and the potential risks associated with it.
Submission of an application: The applicant must submit an application to the CDSCO for registration of the medical device. The application must include a variety of information, such as the technical specifications of the device, the manufacturing process, and the results of any safety and efficacy testing.
Inspection of the manufacturing facility: The CDSCO will inspect the manufacturing facility to ensure that it meets the required standards of quality and safety.

The CDSCO medical device registration process can be complex and time-consuming. It is important to work with MedDev Experts to ensure that the application is submitted correctly and that the registration process is completed smoothly.

Fees for CDSCO Medical Device Registration

Registration Fee to

Manufacture Class A or Class B Medical Devices (MD 5 and MD 6) is ₹5,000 for one manufacturing site and ₹500 for each distinct medical device.
Manufacture Class C or Class D Medical Devices (MD 9 and MD 10) is ₹50,000 for one manufacturing site and ₹1,000 for each distinct medical device.
Conduct pilot or pivotal clinical investigation is ₹1,00,000/-
Sell, stock, exhibit, or offer for sale or distribute a medical device including In-Vitro diagnostic device (MD 42)

Registration Fee to Import licenses:

For Class A medical devices other than in-vitro diagnostic medical devices is $1,000 for one manufacturing site and $50 for each distinct medical device.
For Class B medical devices other than in-vitro diagnostic medical devices is $2,000 for one manufacturing site and $1,000 for each distinct medical device.
For Class A or Class B in-vitro diagnostic medical devices is $1,000 for one manufacturing site and $10 for each distinct in-vitro diagnostic medical device.
For Class C or Class D medical devices other than in-vitro diagnostic medical devices is $3,000 for one manufacturing site and $1,500 for each distinct medical device.
For Class C or Class D in-vitro diagnostic medical devices is $3,000 for one manufacturing site and $500 for each distinct in-vitro diagnostic medical device.

Frequently Asked Questions About CDSCO Medical Device Registration

What is CDSCO medical device registration?

CDSCO medical device registration is the process of obtaining authorization from the Central Drugs Standard Control Organization (CDSCO) to market or manufacture medical devices in India.

What are the classes of medical devices in India?

Medical devices in India are classified into four classes based on their risk level:

Class A: Low risk
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High risk

Who is responsible for approving medical device registration in India?

The authority responsible for approving medical device registration in India depends on the risk class of the device:

Class A and B devices are approved by the State Licensing Authority.
Class C and D devices are approved by the CDSCO.

How can I get help with CDSCO medical device registration?

MedDev Experts is a CDSCO Medical Device Regulatory Consultant in India who can help you with CDSCO medical device registration. MedDev Experts can help you with the application process, prepare the required documentation, and navigate the regulatory requirements.

What are the benefits of having a CDSCO medical device registration?

Having a CDSCO medical device registration gives you the legal authorization to market your medical device in India. It also gives you the confidence that your device meets the required standards of quality and safety.

What are the risks of not having a CDSCO medical device registration?

The risks of not having a CDSCO medical device registration include:

Your device may be seized by the authorities.
You may be fined or imprisoned.
You may be sued by patients who are injured by your device.

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