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...
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...
Asia
From September 26th, 2018, CDSCO is advising that companies looking for blood product clearances forgo the physical applications and use the new Sugam online portal. In an effort to gradually expand the use of Sugam, India CDSCO has allowed companies to choose...
EU MDR/IVDR
India’s health ministry, the Central Drugs Standard Control Organization (CDSCO), has amended its Medical Devices Rules 2017 to simplify the approval process for in-vitro diagnostic (IVD) devices. All NABL-accredited labs will have the power to carry out...
