CDSCO’s updates for Test Kits and Drugs – Imports and Regulatory Approvals
The Indian CDSCO has issued several notices in order to keep up pace with requirements for the ongoing pandemic. They have implemented rules to fast track approvals and also bought in a new amendment on 11th February 2020, wherein apart […]
Read MoreGrouping Guidelines for Medical Devices Applications:
The Government has set certain grouping guidelines in respect to the Medical Devices Rules 2017,here by notifies that the grouping of medical devices for a person who applies for licence to import or manufacture for sale or distribution of medical […]
Read MoreGovt issues notification to bring all medical devices under CDSCO to structure and build safety & quality:
The Government has increased scrutiny on medical devices, after the Johnson & Johnson faulty hip implants case judgment from Supreme Court, which made many people permanently disabled due to faulty devices. The government plans to bring all medical devices, including […]
Read MoreNew Regulatory System In India And List of Documents Required
The Indian drug regulatory system which was formed in 1940, created Drugs & Cosmetics rule The Drug rules were been framed in 1945 to give effective support to the Drugs & cosmetic Act. This two Act and Rules been amended […]
Read MorePost-Approval Changes for Medical Devices in India
The post approval changes are the changes made to the Medical products which have received approval from the CDSCO. The changes of the medical product that results in the impact of the changes on the quality of approved products to […]
Read MoreNew Additions to CDSCO’s list of Medical Devices:
All medical devices in India follow a regulatory framework under the Drugs and Cosmetic Act (1940). Under this the CDSCO has released a new medical device rule “Medical Device Rules (MDR), 2017” to maintain global standards in Manufacture, import and […]
Read MoreCDSCO added more Medical Devices in Drug Act
The Central Drugs Standard Control Organization (CDSCO) is the Indian licensing authorizing for approving any new Medical devices, Drugs and Pharmaceuticals which is to be imported to India. The CDSCO has released a new Medical device rule “Medical Device Rules […]
Read MoreFrequently Asked Questions about Medical Device Rules, CDSCO DCGI India
The Indian Government has made many changes in the rule of selling, manufacturing, importing and registeringof medical devices in India. The main object of this new rule is to simplify and to ensure the high safety and performance of medical […]
Read MoreMedical Device Rules India, 2017: Classification of Medical Devices Regulations and Regulatory Approval for Registration
The classification of medical devices rules along with regulatory approval and registration by the CDSCO is under the control of Drug Controller General of India (DCGI). All medical devices in India follow a regulatory framework that is based on the drug regulations under the Drugs […]
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