Medical Device Design and Development as per ISO 13485:2016
Regulatory compliance and following international industry standards are vital for medical device production. Unlike other industries, designing and developing medical devices is a complex process because of regulatory demands. Any failure to meet regulatory design...
License For Conducting Clinical Investigation in India: A Guide
Medical device manufacturers/importers who wish to conduct a clinical investigation in India need to obtain permission from the CLA. The CLA is the Central Licensing Authority (CLA) and functions under the CDSCO. The CDSCO is the Central Drugs Standard Control...
India’s First Medical Devices Center of Excellence (COE)
The Government of India has taken several steps to support the Indian medical devices industry. The government aims to make India the global manufacturing hub for high-quality and safe medical devices. Initiatives have been taken to boost foreign direct investments,...
AiMeD Seeks Hike in Customs Duty for Medical Devices
The association of Indian medical device industry (AiMeD) is a platform for Indian medical device manufacturers and represents the Indian medical device industry. The platform acts as a single point of contact and provides various services to medical device...