Set by India's Central Drugs Standard Control Organization (CDSCO), the new guidelines will regulate the import, manufacture and sale of all sterile devices in India, including cardiac stents, drug eluting stents, catheters, and orthopedic implants.
The rules were recently clarified by the CDSCO after numerous requests both from inside and outside India and finally came into effect on 29 June 2006.
"From a situation where regulations were lacking, India has progressed and the new guidelines are set to bring additional discipline to the medical devices sector," said Dr Umakanta Sahoo, director of Chiltern International, Mumbai.
"This will fuel confidence in the suppliers and manufacturers in India."
Companies now have 60 days to obtain a license for the medical devices they manufacture in India.
From now on device manufacturers will have to pay a registration fee of $1,500 (€1,173) per manufacturing premise and a fee of $1,000 per single medical device.
For each additional type of device, firms will need to pay an extra fee of $1000, unless the medical device only varies in size or shape without any change in the material or method of use.
Devices which are currently in use will be permitted to be sold for the time being up to a period of six months, until an application is approved or rejected.
From now on if a company intends to make a device in India that has not been manufactured in the country before, they would not be allowed to begin manufacturing without the regulatory approval.
The rules also specify that the importers, stockists and retail sellers of medical devices must obtain appropriate sale licenses from the State Licensing Authorities for the medical devices they are dealing in, within the next three months.
These new guidelines are the latest in a number of regulatory reforms aimed at putting India's pharmaceutical industry standards on par with the west, as more and more international pharma firms look to use the country as a low cost research and manufacturing destination.
India's regulatory framework is now compliant to international standards in areas such as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and the 2005 amendment to the schedule Y of the Drugs & Cosmetics Act has been moving India towards the acceptance of International Conference on Harmonisation (ICH) guidelines for clinical research. The implementation of the product patent act has also confirmed the country's willingness to accept global confidentiality and data security.
However, medical devices have been neglected in these reforms - until now.