Webinar + Square Table (Munich): The Indian Medical Device Industry, Road Ahead
23. October 2017, München
The Indian Medical Devices Industry is going through a regulatory churn of sorts. The government recently exercised its extra-ordinary power and fixed prices of knee implants. Unlike coronary stents whose prices were also fixed sometime back, knee implants were not officially recognized as “essential” for the country when their prices were fixed. Many other such “non-essential” medical devices appear to be on the government’s radar for price control.
On a separate note, earlier in the year, the government introduced of a completely new regulatory regime for medical devices to be effective January 1, 2018. The new regime is expected to regulate all medical devices without exception, including in-vitro diagnostic devices (IVD) and embedded software. This development is a major departure from the present scenario where the government regulates just 15 categories of medical devices. The new regulatory regime has introduced new provisions for business sensitive areas such as shelf life and mandatory recalls that may impact current operations. Clinical research of medical devices has also been revamped under the new regime. The introduction of the new regulatory regime was quickly followed by a major change in labelling requirements for presently regulated medical devices, that will also be effective from January 1, 2018.
There is no denying that a quick brush-up of the regulatory developments in the Indian Medical Devices Industry is now unavoidable. Please join us and our experts from India in a round-table during which they will apprise you of the business-critical developments in the regulatory framework of medical devices in India.
The event is 'by invitation only' due to limited capacity at the venue. To confirm your interest, kindly register here. There is no participation fee for this event. The conference language is English.