P A FrancisWednesday, September 27, 2017, 08:00 Hrs  [IST]

The new set of Medical Devices Rules 2017, separating medical device industry from the pharmaceutical sector, is slated to take effect from January 2018. The MD Rules are expected to regulate all aspects and activities pertaining to medical devices such as manufacture, sale & distribution, imports & exports, labelling, conducting of clinical trials, registration of laboratories for carrying out tests and recall of devices. Although medical devices are considered to be as critical as medicines for treatment of human illness they remained largely outside the purview of any regulatory control for a long time in India. And for the first time the Central government took a major step to rectify this inadequacy by drafting the MD Rules. These Rules are also expected to ease the process of obtaining a license for manufacture and sale of medical devices besides conducting clinical trials. The new Rules propose to classify medical devices into four categories based on their risk type - Class A, B, C and D. A and B are low risk devices whereas C and D classified as higher risk products. The manufacture of Class A and B devices will be licensed by the State Licensing Authorities whereas the manufacture of Class C and D devices will be regulated by the Central Licensing Authority. An important aspect of the MD Rules is that they seek to evolve a culture of self-compliance by manufacturers with manufacturing licences for Class A medical devices will be granted without prior audit of the manufacturing sites. The manufacturers may be allowed to self-certify their compliance with the requirements and based on such certification, the licence will be issued. However, a post-approval audit of the manufacturing site will be carried out by the notified bodies to check conformance with the Quality Management System.
Perhaps the most notable feature of MD Rules is with regard to licensing of products. For the first time in this sector, there will be no requirement to periodically renew the manufacturing and import licences. This would mean that manufacturing and import licences will remain valid until they are suspended, cancelled or surrendered. And the entire process from the submission of an application to granting of a licence, will be managed by an online electronic platform. These major changes in the regulations of this sector is certainly a bold initiative from the part of the government. Now what is to be seen is the compliance level of these Rules from the industry and trade. Currently, MD sector in India is not that developed like pharmaceutical industry and more than 70 per cent of India’s requirement of devices and equipments are being imported as the domestic production is restricted to low technology and disposable items. At the same time, demand for these products has been steadily growing with a sharp rise in the life style diseases in the country. Medical devices are life saving products and have to be produced with quality materials and as per good manufacturing practices. Most of the units engaged in the manufacture of medical devices are small and do not follow GMP voluntarily and no standards have been laid down for the materials used. Quality, safety and fair pricing are three factors that determine the growth of any industry and that very much applies to medical devices too. The new set of MD Rules need to address all these issues to make it a responsible industry segment.