Regulation of all Medical Devices under CDSCO Directive
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Regulation of all Medical Devices under CDSCO Directive
CDSCO, the Central Drugs Standard Control Organisation is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices. Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Device and its positioning with the Ministry of Health and Family Welfare.
The Indian Government has announced its plan to bring all Medical Devices, including Implants and Contraceptives under a review of the Central Drugs Standard Control Organisation.
What are Medical Devices under CDSCO?
A Medical Device is any article, instrument, apparatus, machine, implant or reagent that is manufactured, sold, represented for use in the diagnosis, treatment, mitigation, prevention or care of human or animal disease, disorder, condition or pregnancy.
Medical Devices are divided into 4 categories according to their risk levels under CDSCO which needs licensing from the concerned authority to conduct various activities like sale, distribution, import and manufacture in the country.
Classification and Types of Medical Devices under CDSCO
Medical Devices are Categorized into 4 Classifications under CDSCO based on their extent of risks.
| Category | Amount of Risk |
|---|---|
| A | Low risk |
| B | Low to moderate risk |
| C | Moderate to high risk |
| D | High risk |
There are 37 kinds of Medical Fields consisting of nearly 200 Medical Devices in each category.
Types of Medical Devices
There are two types of Medical Devices
- Notified Devices: Notified Devices are the Medical Devices that are regulated under the Medical Devices Rules, 2017 by the CDSCO.
- Non-Notified Devices: Non-Notified Devices are Medical Devices that have not been mentioned under Notified Devices in the official gazette released by the government of India.
Risk based classes of Medical Devices under CDSCO Directive
There are two types of Medical Devices
- Class A: No pre-inspection is required; SLA will issue the license on Form MD-5.
- Class B: A notified body will inspect the premises; SLA will issue the license on Form MD-5.
- Class C & D: Officers from CDSCO will inspect the manufacturing premises, and CLA will grant the license on MD-9.
Conclusion
CDSCO is Constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of Medical Product manufactured, imported and distributed in the country. Its vision and mission is to protect & promote public health in India and to safeguard and enhance the public health by quality and safety of Medical Devices.
Frequently Asked Questions
What is CDSCO?
CDSCO stands for Central Drugs Standard Control Organisation
Who regulates Pharmaceuticals and Medical Devices within CDSCO?
The Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and its positioning with the Ministry of Health and Family Welfare.
What are Notified Devices?
Notified are the devices which have been regulated under Medical Device Rules,2017 by the CDSCO.
What is a CDSCO certificate for medical devices and when is it required?
A CDSCO certificate for medical devices is mandatory for manufacturers and importers of medical devices in India. It ensures that the devices meet the safety, quality, and regulatory standards as specified by the Central Drugs Standard Control Organization (CDSCO). Expert guidance for obtaining certification, compliance, and documentation is available at CDSCO Certificate for Medical Devices.
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