India - Medical Devices (Amendment) Rules, 2020
The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare (MoHFW), Government of India issued a draft of Medical Devices Rules, 2017 through a gazette notification (No. 724) published on October 17, 2017. Medical devices regulations primarily focused on the quality and safety control to ensure the highest standards assurance of a medical device. It has been classified according to patient risk in different classes (Class A, B, C & D) to ensure that patients have access to high quality, safe, and effective medical devices, by restricting their access to the unsafe and sub-standard products. Further it was ammended to Medical devices (Amendment) Rules 2020: - to regulate the Clinical Investigation, Manufacture, Import, Sale and Distribution of the medical devices in the country. - the Medical Devices Rules, 2017 are harmonized with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices, which will foster Make in India also. Registration,
application/submission of documents, testing, followed by
audit/inspection that may be needed for certain class of medical device,
is the process of obtaining the manufacturing license. Validity of the registration/ License: 5 years |
Source Link:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/