Centre notifies new rules on medical device

The Union government has notified a set of new rules to regulate the medical device sector – worth thousands of crores and growing.

For the first time, the rules will make a distinction between medical devices and drugs and pharmaceuticals, creating separate standards to monitor the two verticals.

The Medial Device Rules 2016 suggest categorisation of devices into four groups depending on the risks associated with the device. The rules are accompanied by a detailed schedule specifying how hundreds of types of devices being sold in the market would be classified.

Those with the least risk such as syringes, wheelchair or walking stick would come under Category A, whereas implantable devices like stents or pacemakers would be considered Category-D instruments.

The rules propose creation of medical device testing officer and medical device officer posts for regulations.

They also spell out plans to set up specialised facility for testing medical devices.
A medical device-testing centre will have to be accredited by a national accreditation body.

The draft notification is open for public comments for 30 days, following which it would
be finalised.

The new rules will fulfil a longstanding demand of the medical device industry to treat them differently from drugs and pharmaceuticals, as basic principles are different to a large extent.

The industry, however, is not completely satisfied with the new rules. “We are disappointed that some of the points agreed to by the government have not found place in the current draft,” Director General of Medical Technology Association of India, Pavan Choudary, told DH.

According to the rules, the manufacturing or importing companies have to have a licence every five years.

The industry, however, sought for a time frame of 10 years at least for orthopaedic implants like metal screws and plates, which the government rejected.

The medical device sector in India is heavily import-driven as of now. Ranging from the shelf life of a device to the date of sterilisation, the new rules also specify what the labels would carry for patient safety. For the existing products, manufacturers and importers would have to obtain a licence within 180 days from the date of the final notification.

The rules will be in place till the government comes out with a separate legislation to regulate the Rs 30,000-crore medical device sector.