An import license is a prerequisite for starting a business to sell or distribute medical devices. Having an import license gives a clear idea about the specification and standards of imported Medical devices.
An import license for new medical devices (Form MD 26 & MD 27) is a prerequisite for starting a business to sell or distribute medical devices. Having an import license gives a clear idea about the specification and standards of imported Medical devices.
It also guarantees the compliance of Medical devices with Quality Management System standards
Thus, it is advisable to have a proper import license due to the strict rules and regulations of the regulatory authority of India.
The import license allows the government to know the quality of Medical Devices so, the customers know that it is safe to use and is trustworthy.
An import license for new medical devices has many benefits, which can help the manufacturer or importer. The person can sell the Medical Device without any legal problems, and it also ensures the safety of the intended population.
Form MD 26
Form MD 27
Any person who wants to import/manufacture Medical devices in the Indian market needs to have an import/manufacturing license issued under the Drugs and Cosmetics Act, 1940 by the regulatory authority of India CDSCO.
CLA is responsible for the import of all the classes of MD. Form MD 26 is for getting permission from CLA either for manufacturing/importing Medical devices which do not have predicate devices in India, while permission is granted through Form 27. In this blog, you will know the several benefits of an import license.
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