Ministry of Health and Family Welfare, India propose use of American Standard Test Methods for medical device conformance
India’s Ministry of Health and Family Welfare has proposed recognizing American Standard Test Methods (ASTM) as acceptable tools for demonstrating conformance of medical devices to safety and conformance requirements and obtaining market access in the country. The notification would amend India’s Medical Device Rules, 2017 to allow medical device market applicants to use ASTM methods to demonstrate […]
CDSCO India: Regulatory updates on Medical device and IVDs announced
Central Drugs Standard Control Organization (CDSCO), India has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic medical devices. List of regulated medical devices- CDSCO has added ultrasound equipment to its list of medical devices falling under regulatory requirements in India. Compliance deadline of November 1, 2020 has been set for registration […]
CDSCO added eight medical device types to list of regulated devices
Central Drugs Standard Control Organization (CDSCO), Indiaexpands oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020. According to the new CDSCO notice, the following device types will require registration and import licensing under the Medical Device Rules, 2017: All implantable medical devices CT Scanning […]
About Author
STARK BLOG
Add Short Descriptiop From Users > Your Profile > Biographical Info
