Draft rules classify medical devices

Medical devices to get licences within six months of notification

The central government has proposed that all unapproved medical devices marketed in the country would have to be licensed within six months of the draft rules, announced on Wednesday, being notified.

Out of the thousands of medical devices in the market, only 15 are regulated by the Drugs Controller General of India (DCGI). This has resulted in the Indian market being flooded with low-quality medical devices.

Medical devices licensed under the old rules would have to get fresh licences within 18 months. In case a licence issued under the old rules expires after 18 months, licence for a new application must be filed at that point, said the draft rules.

The last date for public to submit their comments on the draft rules is August 27. The government would consider those comments and then notify the rules.

Medical devices will be classified based on the severity of the associated risk. Devices with the lowest risk would be classified as Class A; the ones with low moderate risk as Class B; the ones with moderate high risk as Class B and the ones with the highest risk as Class D.

Class A devices will not be regulated. The Centre or the state government will appoint medical device testing officers. To get a licence for a Class B device, an audit by such a testing officer will be made mandatory. A central medical device testing and evaluation centre will be set up. For Class C or Class D devices, an audit by such testing centres will be mandatory.

The DCGI will be the central licensing authority to enforce rules relating to import and manufacture of Class C and Class D medical devices. DCGI will also enforce regulations regarding clinical investigation and clinical performance evaluation of medical devices. The respective state drug controller will be the state licensing authority responsible for enforcing rules in matters relating to manufacture of Class A or Class B medical devices.

It will also enforce rules related to sale, stock, exhibit or offer for sale of medical devices.

To boost exports of medical devices, the government has proposed to designate an entity or a government organisation as the National Accreditation Body. Once a medical device company receives such an accreditation, the trust in that brand will increase, making export easier. LICENCE LAWS

• The medical devices sector is largely unregulated; there are thousands of devices in market yet just 15 are regulated
• All unlicensed medical devices, which are being marketed in the country, will need to apply for license within a period of six months
• Medical devices to be classified based on the severity of the risk associated with it
• The devices with the lowest risk would be classified as class A; the ones with highest risk as class D
• The government can designate any institute, government orgnisation or a company as National Accreditation Body. Such accreditation of medical devices will boost exports