CDSCO Medical Device Import License - Process,Types & Classification, Fee
CDSCO, being India’s most powerful Organization, refers to the Central Drugs Standard Control Organisation. It is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical devices.
To import medical devices into India, manufacturers have to fulfill all the standards of quality & efficacy to get access to the Indian market. In India, the Distribution, Sale, Manufacture and Import of Cosmetics, Drugs, Medical Devices are regulated under the provisions of the Drug & Cosmetics Act, 1940 and Rules, 1945.
What is a Medical Device, Types and Classification?
A Medical Device is an article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.
Types of Medical Devices
- Notified Devices: Notified Devices are the Devices that are regulated under Medical Devices Rules, 2017 by the CDSCO.
- Non-Notified Devices: Non-Notified Medical Devices are every medical device that has not been mentioned under notified medical devices in the official gazette released by the government of India.
Classifications of Medical Devices
The commodity that is packaged needs to have a plain, conspicuous, and definite declaration. There are a required declarations that needs to be mentioned on the each package as mentioned below-
| Category | Amount of Risk |
| A | Low risk |
| B | Low moderate risk |
| C | Moderate high risk |
| D | High risk |
What is CDSCO Registration for Medical Device Import License?
CDSCO Registration is a process to obtain an approval from the Central Drugs Standard Control Organisation to ensure the efficiency and the quality of the Medical Devices to be used by the masses.
CDSCO along with state regulators are responsible for authorizing licenses for Medical Devices. It is a mandatory certificate to be obtained by the manufacturers who deals with medical devices especially in the Import activity in India. The Indian Government has announced its plan to bring all Medical Devices, including implants and contraceptives under a review of CDSCO.
Benefits of CDSCO Medical Device Import License
Medical Device Import License provides several benefits as:
- Safeguard the Public Health: The vision and mission of Central Drugs Standard Control Organisation is to protect, promote, safeguard, and enhance the public health by assuring the safety, efficacy, and quality of Medical Devices to be consumed by the masses.
- Regulatory Compliance: Holding a CDSCO Medical Device Import License acts as proof of working under legal terms and conditions. It removes any hindrances as in custom stoppage and ensures that the product is fulfilling the needs of the holder while not being hazardous to people.
- Increase in Revenue and Turnover: CDSCO Certificate serves as proof of legal compliance, a process to ensure that an organization follows relevant laws, regulations, and business rules. It builds trust and confidence among the public, which results in profit.
CDSCO Fee for Product
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Monitrix.
Documents required for CDSCO Medical Device Import License Process
Important documents required in the process are as follows:
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- Covering Letter
- Form MD 14
- Description of Medical Letter
- Justification of Quantity
- Test Protocol
- Quality Certificate of the Manufacturer
- Instructions for use
- Undertaking (device will be imported exclusively for only specified purpose)
- Undertaking from the testing laboratory
- Fee Challan
- Copy of BA/BE site registration as approved by CDSCO in case of BA/BE approved sites registration
- Manufacturing license or wholesale license (in the case of Import)
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Conclusion
CDSCO stands for Central Drugs Standard Control Organisation which is responsible for authorizing licenses for Medical Devices. For Importing, manufacturing,selling and distributing of Medical Devices, CDSCO license is important under the Drugs and Cosmetics Act,1945. The CDSCO License can also act as a Certificate of permission to deal with Medical Devices in India carrying several benefits with itself.
Why Monitrix
At Monitrix, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
