Overview of Medical Device Rules – India | HCL Whitepaper

DOWNLOAD THE WHITEPAPER

The MEDICAL DEVICE RULES - INDIA Guideline provides minimum requirements for the medical devices. These Rules envisage creation for all stakeholders including innovators, manufacturers, providers, consumers, buyers and regulators for the manufacturing, labeling, testing, and sale of medical devices.

The MEDICAL DEVICE RULES - INDIA Guideline provides minimum requirements for the medical devices. These Rules envisage creation for all stakeholders including innovators, manufacturers, providers, consumers, buyers and regulators for the manufacturing, labeling, testing, and sale of medical devices.

This is the first legislation in India dealing specifically with medical devices. This medical device rules is simplified requirement for foreign manufacturers for the import of medical devices through an authorized agent.These rules are  transparent and predictable regulatory framework will boost the confidence of investors and, as a consequence, the quality and range of products and services will improve and business burdens will be reduced.

The entire process starting from submission of application to grant of permission/licence will be processed through online electronic platform. Timelines have been defined for most activities at the regulators end. The new Rules will help in developing a quality standardization framework in India at par with international standards.