On April 28, 2006, the Indian government extended the last date for device registration from April 30, 2006 to June 30, 2006. This extension gives medical device manufacturers, who have devices that now require registration in India, about 2 more months to submit their dossiers.
As mentioned in last month’s newsletter, there are a number of items that need to be provided in the dossier, which are outlined in Form 40 and Schedules I and II. Providing only partial data in the application (with the rest to be submitted later) will not work, according to our local sources in India. One of the risks of submitting partial data is that the manufacturer would have paid the application fees of $1,500 per factory and $1,000 per product, and then the application may be rejected. The manufacturer might need to start the process all over again (and perhaps have to pay the fees again).
Despite this extension until June 30, the consequences of a late application are not spelled out yet. In addition, no one can commit that a late application will or will not be accepted.