India
India announces the adoption of new amendments to current medical device regulations that will significantly change the whole medical device framework. In particular, the new document introduces changes to the Medical Devices Rules 2017 and the Drugs and Cosmetics Act...
India
Indian policy thinktank NITI Aayog has not denied proposals to classify medical devices under the Central Drugs Standard Control Organization (CSDCO), but pushes instead for the implementation of new laws to regulate medical devices. India and Medical Device...
India
Experts and pharmaceutical companies in India may grant terminally ill patients access to drugs that have not yet been cleared through clinical trials. The new policy would serve as a last resort for patients who are left with no available approved treatments. A draft...
Asia
Designation According to the notice published by the Medical Devices Division of CDSCO, the regulating authority registered six notified bodies, authorizing them to perform medical device manufacturing site audits, the appropriate requirement set forth by Medical...
Asia
In India, the institution that oversees medical device regulations is the Central Drug Standard Control Organization (CDSCO), which is part of the Ministry of Health and Family Welfare. The Medical Device Rules, 2017, which went into effect on January 1, 2018, is the...
