Last year, the CDSCO (Central Drugs Standard Control Organization) published new rules for Medical Devices. These rules have gone into force at the beginning of this year, exactly on the 1st of January 2018. There was a need to distinguish between Medical Devices and pharmaceutical products, as Medical Devices have been considered Pharmaceutical products before the implementation of the new rules. Apart from that, local manufacturers need to set up their industries in a more conducive environment. So, the Department of Pharmaceuticals was named as a Notified agency.

Domestic manufacturers as well as imports will be benefited from these new rules.

We are going to mention the most important points of the Medical Devices New Rules in this post.

Classification

The new rules classified the devices according to the level of risk. Importers and manufacturers need to classify their products according to the following list

Table 1: Device Classification System, per Medical Device Rules, 2017

Quality Management System (QMS) Assessment

A Quality Management System (QMS)assessment for class A and B products could be implemented by the Notify Body. The Notify Body could also assist the CDSCO with class C and D products assessment.

For foreign manufacturers, an inspection could take place on the site, either by the CDSCO or an accredited Notify Body.

You can check all the accredited Notify Bodies on the CDSCO website.

Registration

From now, for the obtention of all licenses, these new rules are going to be essential. All the applications will be through SUGAM, the Ministry of Health and Family Welfare online system.

Manufacturing licenses of class A and B devices will be regulated by the State Licensing Authority (SLA), and class C and D devices’ licenses will be regulated by the Central Licensing Authority (FSSAI). The QAR above mentioned should be submitted with the application for class B, C and D devices. On the other hand, class A devices QAR should be submitted within 120 days from the day the license was given.

Import licenses are required but QAR is not required in this case. Foreign manufacturer should have an authorized agent to hold the license and present it to the Central Licensing Authority. The agent also has to do the post market surveillance and distribution of the devices.

In case the Central Licensing Authority carry out an inspection of the foreign manufacturer, a complete Technical File and Import License application will be essential, and these should be submitted to the Central Licensing Authority.

The below table shows the timeline of obtaining both licenses.

Table 2: Timeline to obtain Manufacturing / Import Licence for medical devices

Clinical Investigation

There will be two phases, pilot clinical investigation and pivotal clinical investigation. The first one refers to the exploratory study, and the second one refers to the confirmatory study.

A clinical investigation won’t be required if an Import License of devices that have not been declared in India and have a Free Sales Certificate (FSC)issued from Australia, Canada, Japan, the United States, or member states of the European Union.

For in-vitro diagnostics devices, Clinical Performance Evaluation will be mandatory. In contrast, for academic clinical trials, prior approval of clinical trials won’t be required.

Labeling

Manufacturers need to follow the labeling requirements of the Legal Metrology (Packaged Commodities) Rules, 2011. Apart from that, the UDI (Unique Device Identification) number must appear on the label of each device, this is not effective yet, but will be effective by the beginning of 2022.

Recalls 

All products that are dangerous or harmful for the user must be recalled by the manufacturers or importers providing a reason for the recall.