Apply for Medical Device Registrations In India
- Medical Device Registration in India is managed by the CDSCO (Central Drugs Standards Control Organization) under the Ministry Of Health & Family Welfare. The CDSCO body regulates all medical devices, IVDs and cosmetics manufactured, sold or imported (from a foreign manufacturer) in India. The registration of medical devices ensures that they meet all safety standards as per the government guidelines.
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OVERVIEW
Overview Of Medical Device Registration
Medical Device Registration in India is managed by the CDSCO (Central Drugs Standards Control Organization) under the Ministry Of Health & Family Welfare. The CDSCO body regulates all medical devices, IVDs and cosmetics manufactured, sold or imported (from a foreign manufacturer) in India. The registration of medical devices ensures that they meet all safety standards as per the government guidelines.
Any business interested in obtaining CDSCO registration in India needs to comply with the rules and procedures laid down by the CDSCO under the Drugs and Cosmetics Act, 1940, the Medical Device Rules, 2017 and the Cosmetics Rules, 2020.
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Benefits Of Medical Device Registration
- Regulatory Compliance - It ensures that your products meet the health and safety regulations. The CDSCO registration also helps you to avoid penalties, if any.
- Market Access - Expand the market with the registered devices so you can easily sell your products in more countries to reach the wider audience. This results to more business and sales opportunities.
- Credibility and Competitive Advantage - Registration of the medical devices shows that product is safe and reliable. This builds trust with doctors, patients, and consumers, making your products more attractive compared to unregistered competitors.
Role Of ELT Corporate For MDR License
- Facilitated in acquisition of 2500+ regulatory licenses with expedited query handling.
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- Believe in transparency in communication and keeping proactive approach
Types Of Medical Device Registration
- The medical devices in India can be broadly categorised into different classes based on the nature of devices or products, its intended use, as well as the specific regulatory requirements.
Type Of Registration | Application Form |
Manufacturing License Registration |
|
Import License Registration |
|
Registration for In Vitro Diagnostic (IVD) Devices |
|
Manufacturing License Registration For In Vitro Diagnostic (IVD) Devices |
|
Test License Registration |
|
Sale, Stock and Exhibit License |
|
Licensing Authorities for CDSCO Registration
There are two licensing authorities that grant CDSCO registrations for manufacturing and import in India – State Licensing Authority (SLA) and Central Licensing Authority (CLA). All the product classes of medical devices/ IVDs/ cosmetics have different application processes, requirements, as well as licensing authority that grants the license. The procedure to obtain a CDSCO license can be complicated in India. Therefore, if you want to avoid any chances of rejection of your application, it must be handled by Medical Device Registration experts in India.
State Licensing Authority (SLA)
The CDSCO registrations of medical devices and IVDs falling under Class A and B are issued by the SLA for manufacturing, loan and wholesale license.
Central Licensing Authority (CLA)
The CDSCO registration of medical devices and IVDs falling under Class C & D are issued by the CLA for import, manufacturing, loan and wholesale license, and import license for cosmetics in India.
Frequently Asked Questions
Yes, After October 1, 2021 every medical device need to registered. Before importing devices in India medical device import license with the CDSCO is mandatory.
The manufacturer of medical devices, authorized agent or authorized representative, and importers can submit the form for the registration of CDSCO.
To register Medical devices in India every product category have different time duration such as:-
- Non Notified Class C & D medical devices cab be register currently through the e-portal.
- All A & B Medical devices will typically takes 6 to 9 months for the device approval.
- Product with reference country approval takes less time and quicker review response.
Medical Devices are classified into 4 categories in India accordance:-
It is devices according from low risk Class A to high risk Class D.
- Class A
- Class B
- Class C
- Class D
Who Can Apply for CDSCO Registration in India?
- Domestic Manufacturers of Medical Devices/IVDs
- Importer of Medical Devices/IVDs/Cosmetics
- Foreign Manufacturer of Medical Devices/IVDs/Cosmetics
- Authorised Agent of Medical Devices/IVDs/Cosmetics
- Indian Subsidiary of Medical Devices/IVDs/Cosmetics
Classification of Medical Devices mobile
- Medical devices in India are classified into four categories by the CDSCO based on the risk they pose to a patient:
- Low risk (e.g., surgical dressings, tongue depressors)
- Moderate risk (e.g., hypodermic needles, suction equipment)
- Moderate to High risk (e.g.,implantable pacemakers, hemodialysis machines)
- High risk (e.g., heart valves, implantable defibrillators)
Classification of Medical Devices
- Medical devices in India are classified into four categories by the CDSCO based on the risk they pose to a patient:
- Low risk (e.g., surgical dressings, tongue depressors)
- Moderate risk (e.g., hypodermic needles, suction equipment)
- Moderate to High risk (e.g.,implantable pacemakers, hemodialysis machines)
- High risk (e.g., heart valves, implantable defibrillators)
Process Of Medical Device Registration
- Follow the process to apply for the Medical Device License In India:
- Determine if the product is under notified or not..
- In the case of a foreign entity, appoint an authorized representative.
- Fill out the form for medical device registration.
- Obtain a Certificate of Registration as prescribed.
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Additional Documentation
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Additional Documentation
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Additional Documentation
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Re-Registration Or Renewal Of Medical Device License
- The renewal and re-registration of medical devices is mandatory if your license is expired. You have to apply for the renewal before the expiry under the experts guidance.
Our Clients
Our Testimonials
ELT Corporate's team secured our CDSCO import licence despite the document challenges required to obtain this licence. Their efficient team guided us throughout the entire process and made it smooth for us.
ELT Corporate helped us get our CDSCO import license even though we had a lot of complicated paperwork to handle. Their team was super efficient and guided us every step of the way, making the whole process easy.
Getting our CDSCO import license seemed impossible until we found ELT Corporate. Their knowledgeable and professional team handled all the tricky documentation for us. They made the entire process stress-free and quick.
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