Import of drugs in India
All around the World, Persons are in need of medicines; some of the medicines are manufactured and available to them locally. Remaining need of medicine has to be imported from other countries. This enhances the trade of the drugs from […]
Read MoreBudget 2019 Healthcare – Overview:
The Government has revealed the Union Budget for the financial Year 2020on July 5th 2019, experts has suggested that government has increased spending on Healthcare but that may not be enough. People all over India were expecting the Narendra Modi-led […]
Read MoreImportance of Predicate And How to Find The Predicate Device:
The CDSCO is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs and medical products that is been registered within India. In India drug regulatory system which was formed in 1940, created Drugs & […]
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 MoreIndia’s New Medical Device Rules 2017 -Major Changes
2018 has been a very eventful year for Regulatory in India. The Indian FDA Central Drugs Standard Control Organisation (CDSCO) has formally recognized medical devices as a separate division from Drugs with the Landmark Medical Device Rules, 2018. Medical Device Rules 2018: The following are some of […]
Read MoreIVD Classification System: 2018
In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017. IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in […]
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