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How regulatory changes for medical devices sector are impacting manufacturers

Since registration with the government-designated portal is to be followed up with an application for license with the CDSCO, it ensures a sort of a double-checking of the credentials of the manufacturers.

MDR-2017, medical devices, CDSCO, Max Ventilator, ISO 13485
Making ISO 13485 a pre-condition for registration would ensure that indigenous medical device manufacturers are ready to access and compete in the world market and would be treated at par with leading global companies.

By Ashok Patel

Much before the advent of Covid-19 had exposed the crippling inadequacies in the Indian healthcare system in terms of facilities, equipment, manpower and services, the government of India had set in motion a series of rules and regulations for the medical devices and equipment sector.

By way of the overarching Medical Devices Rules (MDR), 2017 coming into force in January 2018, the authorities had set the stage for a quality-driven, safety-led, performance-oriented, and above all, transparency-focused medical device sector in the country.

The MDR 2017 was followed by twin notifications that were issued on February 11, 2020 – one providing a new definition of medical devices, and the other through Medical Devices (Amendment) Rules 2020 inserted Chapter III A in the MDR, 2017 laying out registration requirements for manufacturers and importers.

While these measures are indeed creditworthy paving the way for a more streamlined and integrated regulatory approach to the medical devices sector, how are these regulatory changes playing out from the manufacturers/importers’ standpoint?

MDR 2020 ushers in a separate regulatory framework for medical devices

With the MDR 2020 coming into effect from April 2020 providing an all-inclusive and comprehensive definition of medical devices, the hitherto unregulated sector has been given a due and separate regulatory framework from that of drugs and medicines. For the longest time, only through periodic notifications, specific medical devices were identified for regulation akin to a drug under the Drugs and Cosmetics Act, 1940.

However, from April 2020 onwards, all medical device manufacturers except for those 37 notified until then have been mandated to register themselves with a government-designated portal in order to carry out any manufacturing, distribution, sale and importing of a medical device. This registration process would require submission of name and address of the company as also the address of the manufacturing sites, device details, ISO 13485 certificates etc.  Along with these details, the importers would also have to furnish free sale certificate from the intended country of origin for a particular medical device.

MDR 2017’s risk-based classification system ensures better risk management

Based on the intended use of the device, the risks associated with it and other parameters, a four-fold risk-based classification has been introduced. While devices under Class A are considered low-risk, those under Class B are of low moderate risk, under Class C as moderate high risk and Class D as high risk. This classification system has brought greater clarity among manufacturers in terms of design and material-related risk assessment and management which would enable them to incorporate suitable manufacturing adjustments and upgrading through employment of appropriate risk management tools and techniques.

Timely registration obviates need for licensing for sometime: Allows window for full-compliance 

Notably, for the first 18 months, while this registration provision has been made voluntary, it has been made mandatory thereafter. However, once registered on the portal, an exemption period for acquiring manufacturing and import licenses has been allowed. Accordingly, those relatively lower risk devices under Class A and Class B would be exempted from having to acquire licenses for 30 months while those higher risk devices under Class C and D categories would be exempted from the same for 42 months, from the time of coming into force of MDR 2020, i.e., April 2020.  This period between registration and licensing allows a manufacturer to iron out its existing manufacturing issues in terms of quality, capacity and logistics and supply chain etc readying itself for full compliance before acquiring a license.

Incentivizes new players

The linking of licensing exemption with registration has galvanized and incentivized new device manufacturers to register themselves without delay thereby bringing a large number of device-makers and players hitherto operating in the unorganized sector under the ambit of regulatory framework.

Robust verification regime

Since registration with the government-designated portal is to be followed up with an application for license with the Central Drugs Standard Control Organisation (CDSCO), it ensures a sort of a double-checking of the credentials of the manufacturers.

ISO 13485 prepares manufacturers for a competitive international market

Making ISO 13485 a pre-condition for registration would ensure that indigenous medical device manufacturers are ready to access and compete in the world market and would be treated at par with leading global companies.

Therefore, the coming in of these regulatory changes has certainly addressed the product quality and efficiency aspects of the medical device sector bringing it under a proper regulatory and monitoring framework and must be welcomed by all means. At the same time, they have also raised minor questions on their implementation part with a few sections remaining prone to overlapping interpretations. Now that more than 17 months have already passed since April 2020, we are certain that they would all be sorted out sooner than later. The government could also come up with greater clarity on assembled devices and imported parts used for putting together a device meant for end use.

(The author is Founder and CEO, Max Ventilator. The article is for informational purposes only. Please consult health experts and medical professionals before starting any therapy or medication. Views expressed are personal and do not reflect the official position or policy of the Financial Express Online.)

 

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