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MDR (Medical Device Rules) Registration

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MDR (Medical Device Rules) Registration

MDR (Medical Device Rules) Registration

MDR (Medical Device Rules) is a set of regulations governing the registration and sale of medical devices in India. The CDSCO (Central Drugs Standard Control Organization) is responsible for overseeing the registration and regulation of medical devices in the country.

In order to register a medical device in India, manufacturers must comply with the requirements outlined in the MDR. These requirements include submitting detailed information about the device, its intended use, and its safety and efficacy data.

The CDSCO reviews this information and may require additional testing or data before granting registration. Once registered, medical devices must comply with ongoing regulatory requirements, including labeling and adverse event reporting.

The MDR also classifies medical devices into different risk categories based on their intended use and potential harm to patients. Higher risk devices require more rigorous testing and documentation before they can be registered and sold in India.

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FAQ

MDR Registration stands for Medical Device Rules Registration, which is a mandatory registration process for all medical devices sold or distributed in India. It is regulated by the Central Drugs Standard Control Organization (CDSCO).

The manufacturer or the importer of the medical device is responsible for MDR Registration.

MDR Registration is a registration process under the new Medical Device Rules, 2017, while CDSCO Registration is a registration process under the old Drugs and Cosmetics Act. MDR Registration is more comprehensive and is mandatory for all medical devices sold or distributed in India.

The documents required for MDR Registration include the device description, classification, technical specifications, labeling details, and manufacturing information. In addition, the manufacturer or importer needs to provide the ISO certification and clinical trial data, if available.

The validity of MDR Registration is five years, after which the registration needs to be renewed.

Non-compliance with MDR Registration can result in penalties, fines, and even imprisonment. In addition, the product may be withdrawn from the market.

No, it is illegal to sell or distribute a medical device in India without MDR Registration.

Yes, clinical data is required for MDR Registration if the device is classified as Class C or Class D. For Class A and Class B devices, clinical data may not be required.

The timeline for obtaining MDR Registration depends on the device classification and the completeness of the documents submitted. It can take up to 12-18 months to obtain MDR Registration.