Indian Regulators Propose Changes to Good Manufacturing Practice Requirements for Medical Devices
Questions? Request more information from our specialists
CONTACT USDec 4, 2014
India’s Central Drugs Standard Control Organization (CDSCO) has proposed bringing the country’s Good Manufacturing Practice requirements for medical and in vitro diagnostic devices more in line with those of the ISO 13485 quality management system standard.
Manufacturers with ISO 13485-compliant quality systems already implemented should find the new CDSCO requirements familiar. If regulators ultimately adopt ISO 13485-based QMS requirements, such firms may find it advantageous and less complex to pursue registration of their devices in India.
CDSCO is accepting comments on its draft GMP changes through December 17, 2014. The regulator’s proposed amendments would affect quality system requirements under the country’s Drug and Cosmetic Act.
Author
- Stewart Eisenhart
Related
CDSCO Expanding to Enforce New Clinical Trial Rules in India
Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
Indian Regulators Issue New Registration, Licensing Guidance for Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing.
Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes: