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Regulations to improve quality of medical devices

Definite standards for manufacturers


Definite standards for manufacturers


Make in India 2


Bringing medical devices under Medical Device Rules (MDR) regulation will lead to improvements in the quality of medical devices and consequently an increase in patient safety, says Nishith Desai Associate (NDA).

Wider medical device regulation will also lead to uniformity in medical device standards across all brands and manufacturers thereby reducing danger to patient safety and decreasing the need for constant medical supervision.

Manufacturers will also have a definite set of standards to keep track of as opposed to attempt to set their own methods of validating medical devices, said NDA in comments on the Draft Notification issued in October 2019 by the government.

It is in the right director, said the legal consultancy, which elaborates further:

However, while the intention of the Draft Notification is laudable, clarifications are required from the Central Drugs Standard Control Organization (CDSCO) on how the implementation will take place.

Effective implementation may lead to gains for patients while delayed or ineffective implementation could lead to huge losses for medical device companies.

Even aside from the Draft Notification, the medical device regulation space has been experiencing a lot of activity. Earlier in November, the NITI Aayog – the Indian Government’s policy think tank – submitted a draft bill to the Indian Government proposing to create a separate regulator for medical devices.

The bill, titled the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 also aims to introduce a Unique Identification Number on all medical devices, increase penalties for non-compliance as well as tighten the regulation applicable to clinical investigations.

It is currently unclear how the two legislations will interact with each other or if the proposed bill will replace the MDR. The medical device industry can certainly expect exciting times ahead.

The Ministry of Health and Family Welfare on 18 October 2019 released two draft notifications.

One proposes to bring all medical devices under the ambit of regulation (New Definition Notification).

The other requires the registration of all medical devices on a portal (Portal) developed by the Central Drugs Standard Control Authority (CDSCO) – India’s apex drug regulator – for this purpose (Registration Notification) (collectively referred to as the Draft Notification).

The Draft Notification is the biggest leap that India has taken in terms of medical device regulation after the enactment of the MDR in 2017.

However, there are some concerns with respect to both clarity and expected impact with respect to the Draft Notification as outlined below.

Ambiguity in Timelines for Notifying the Draft Notification

The New Definition Notification states that it may come into force on 1 December 2019 while no date has been specified with respect to the Registration Notification.

However, the New Definition Notification is still in the draft stage and therefore may not be notified before next year.

Regardless, there remains some ambiguity with respect to when both parts of the Draft Notification will be notified. For the registration process to be carried out smoothly, both parts of the Draft Notification should come into force simultaneously.

If only the Registration Notification is notified no device would be required to be registered under the Registration Notification. If only the New Definition Notification is notified, all medical devices will be brought under the regulation of the MDR in one fell swoop without allowing manufacturers and importers to avail of the Exemption Provision.

However, from the language of the Draft Notification, we anticipate that both parts of the Draft Notification will come into force at the same time, with the New Definition Notification kicking off the registration of medical devices under the Registration Notification.

Tight Timelines for Ensuring Compliance

Registering the New Devices is a pre-condition to availing the Exemption Provision.

Therefore, manufacturers and importers will be compelled to register the New Devices to avail the Exemption Provision or not import/manufacture the New Device until they obtain the requisite licenses.

Once the registration process is complete, manufacturers and importers will be required to apply for manufacturing and import licenses with the CDSCO – a process that typically takes nine months to complete.

However, given the large volume of applications the CDSCO is bound to receive, processing the applications may take even longer. Given that the CDSCO is currently staffed to deal with both pharmaceutical as well as medical device related applications, the timelines for processing of the applications may also be impeded.

As a result, manufacturers and importers who have not been granted the required licenses at the expiry of the Exemption Provision despite having registered their New Devices and applied for licenses well in time will be forced to halt operations.

To address this concern, the Exemption Provision should be de-linked from the requirement to register the device. This way, New Device manufacturers and importers will have the full 30 to 42 months to register their New Device.

Additionally, manufacturers and importers who have registered their New Device on the Portal and applied for a manufacturing and import license should be permitted to carry on business activities on a provisional basis at the expiry of the Exemption Provision even though the license has not been granted yet.

This will help stagger the workload on the CDSCO without requiring medical device companies to halt their business activities.

Ambiguities on Registration Process

The details required to be uploaded by the manufacturer and importer specified in Table 2 contemplate the manufacture of import of a medical device as a whole.

However, a medical device could also be partly manufactured in India and partly imported.

Additionally, spare parts of medical devices may also be imported separately for repairing the medical device. Clarification is required from the CDSCO on how registration numbers will be generated for medical devices which cannot be registered as a whole.

The manufacturer or importer is also required to specify the class of the medical device sought to be manufactured or imported when entering the details of the medical device on the Portal.

The CDSCO will therefore be required to classify a large number of medical devices before the registration requirement comes into effect which, given the impending timeline, appears to be a herculean task.

Medical Device Regulation

Medical devices in India are governed under the Medical Device Rules, 2017 (MDR) – a set of rules framed under India’s primary drug legislation, the Drugs and Cosmetics Act, 1940 (D&C Act) – which came into force on 1 January 2018.

The MDR currently only regulates medical devices which have been notified by the Health Ministry for regulation under the MDR. As of this writing, sixteen medical devices are regulated under MDR while 8 others are regulated as drugs.

Four additional medical devices will come under regulation from 1 January 2020, eight more from 1 April 2020 and ultrasound equipment will be added to the list from 1 November 2020.

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