In India, medical devices were regulated as drugs under the Drug and Cosmetic Act 1940. This concept has changed now, with publication on the Indian Medical Device rule 2017, issued by the Ministry of Health and Family Welfare via Notification No. G.S.R, 78(E) issued on 31st January 2017. The Indian Medical Devices Rules 2017 are harmonized with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices. The Indian Medical Devices Rules 2017 consists of 12 Chapters, 8 Schedules, and 40 Medical Devices
As per Indian MDR, the medical devices are classified based on the risk, and this risk is decided on basis of the intended use. The process of obtaining a manufacturing license is dependent on the device classification.
It is the first step in the process of registering your medical device in India. When a device with new technology, or new material, or any new indication of use; is to be placed on the market, the manufacturer must obtain a test license to manufacture a small number of devices to prove its safety and performance.
Medical Device Manufacturers are required to obtain a manufacturing license from CDSCO for manufacturing, sale, or distribution of all classes of a medical device.
As per the Indian MDR, all the medical devices and IVD manufacturers located outside India who want to sell their devices in the Indian market should have an import license.
In the life-cycle of medical devices, post-approval changes are important and are part of it. The organization may require this after they have got approval for manufacture or import due to various reasons.
Device Master File means a detailed information concerning the product which is to be submitted to relevant regulatory authority made in accordance with applicable rules and regulation.
• Establishing and implementing a quality management system
• Support on Device Classifying
• Test license and Manufacturing license
• Sugam portal - submitting the application
• Support during audit
• Responding to the queries
Meet all the regulatory requirements in advance
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