A US medical device manufacturer was looking to introduce a new medical device and expand its market in India and neighboring countries (Class IIa and IIb). The manufacturer sought regulatory support in submission and obtaining approval to market these new products for business expansion.
The scope of Celegence activities was to manage all regulatory activities and ensure full regulatory compliance for medical device registration in India, Sri Lanka, Pakistan, and Bangladesh. The team was expected to work closely with local regulatory authorities to ensure the latest regulation requirements regarding product registration and maintenance were addressed. The team was also expected to engage in regular project monitoring, documentation filing, and timely status reporting.