On 31 January 2017, the Ministry of Health and Family Welfare notified the Medical Devices Rules, 2017 (Rules) under the Drugs and Cosmetics Act, 1940 which would come into effect from 1 January 2018. The Rules have been notified in pursuance of the announcement of the Finance Minister during the Union Budget committing to specify norms for manufacturing medical devices by forming new rules for regulating medical devices. At present, the Drugs and Cosmetics Rules, 1945 (Drugs Rules) regulate 15 categories of medical devices as drugs. Some of the salient features of the Rules are as follows:

Risk based classification

Under the Rules, medical devices (including In vitro diagnostic devices) have been classified into 4 categories based on associated risks into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk) devices. These devices could range from simple devices such as thermometers and disposable gloves to implantable devices such as stents and artificial joints. The manufacturers of medical devices would be required to meet risk proportionate regulatory requirements that have been specified in the Rules.

Standards for medical devices

Under the Rules, the medical devices are required to confirm to the standards laid down by the Bureau of Indian Standards. If no standards for medical devices are specified, they are required to conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission.

Licensing for different activities

The Rules also provide for separate licenses to be obtained for the manufacture and import of medical devices and impose separate conditions to be fulfilled for obtaining these licenses. A unique concept introduced by these Rules is that the licenses will be issued to the manufacturers or importers in perpetuity until they are surrendered or cancelled (as against for a defined renewable term, which has been the norm thus far).

Shelf life restrictions

Restrictions have also been imposed on the shelf life of a device - which may not be for more than 60 months unless a justification to the contrary is presented. The restrictions on the shelf life of imported medical devices, of course, vary depending on the percentage of residual shelf-life as on the date of import.

Quality management systems

So far as the manufacturers’ responsibilities are concerned, the Rules prescribe detailed guidelines on the quality management system that should be used, amongst others, for the design and development, packaging and servicing of medical devices. To keep a check on the manufacturers’ responsibilities, the Rules have introduced a framework wherein certain “Notified Bodies” (accredited by the National Accreditation Board for Certification Bodies) would undertake verification and assessment of the quality management system of Class A and Class B category devices and, if required, be called upon to render assistance for regulation of Class C and Class D devices as well.

Clinical Trials

The Rules also stipulate the regulation of clinical trials of investigational medical devices which, at the first instance, seem to be less cumbersome as compared to the restrictions imposed under the Drugs Rules. Further, the Rules prescribe guidelines to be followed while conducting the trials and also provide for the compensation payable to the subjects of a clinical investigation.

Khaitan Comment:

The Rules do come as a welcome move by the Government, as it seems to remove the manufacture, import and distribution of medical devices from the extensive regulatory checks as prescribed under the Drugs Rules by which they are currently governed. However, certain aspects of the Rules are a cause for concern – for instance, media reports indicate that certain fine-prints of the notification such as limiting the shelf-life of the device to 5 years are an impediment for the industry. However, since the implementation of the Rules is about a year away, the Ministry may take note of these concerns and notify clarifications / amendments to address them.

At this stage, one may merely observe that whilst the Rules have been drafted by the Ministry in close consultation with the stakeholders involved, only time would tell whether the Rules do stem a balance in the regulation of medical devices, which has been long awaited.