Rajdutt Shekhar Singh, Partner, Singh & Associates provides detailed insights into the Medical Devices Rules 2020 and how it is going to help medical devices manufactures when importing or manufacturing devices for the Indian market
The Central Drugs Standard Control Organisation (CDSCO) published the Medical Devices Rules, 2017 which came into force on January 1, 2018. These rules were deemed to simplify the regulatory structure to obtain registration and licenses by importers and manufacturers of ‘medical devices’ which were distinguished for the first time since the Drugs and Cosmetics Act,1940, was enacted. It introduced risk-based classification system and product standards for medical devices, single window clearance, certain and rationalised timelines for obtaining registration and licenses. It also consolidated requirement of obtaining registration certificate and import license into a single license for foreign manufacturers.
On February 11, 2020, the Ministry of Health and Family Welfare (MoH&FW) issued two notifications in the Indian Gazette – a new definition of medical devices [1] and The Medical Devices (Amendment) Rules, 2020, the latter amends the Medical Devices Rules, 2017, and has been effective from April 1, 2020 [2]. The Ministry after consultation with Drugs Technical Advisory Board (DTAB) has intended for a cumulative effect of both these notifications to ensure that all medical devices meet certain standards of quality and efficacy, and for mandatory registration of all medical devices.
The standards of quality and safety of medical devices are regulated in India by the Drugs and Cosmetics Act, 1940 (DCA). The scope of DCA is restricted to only those medical devices which are notified by the Government from time to time as ‘drugs’ (commonly referred to as ‘notified medical devices’). The Medical Devices Rules, 2017 (“MDR”) had been framed under DCA and it laid down comprehensive quality requirements to be followed by importers /
manufacturers / sellers of notified medical devices.
The DCA and MDR ensure quality and safety of notified medical devices at all levels of the supply chain by enforcing a mandatory license requirement. All importers / manufacturers / sellers of notified medical devices must obtain a license from the appropriate licensing authority before undertaking any commerce in notified medical devices.
New definition of medical devices
Up until February 11, 2020, the Government had regulated or notified 37 categories of medical devices as drugs [3]. Vide the above mentioned notifications, the Government can exercise its powers to notify one or more categories of medical devices as ‘drug’ to actually notify a new definition of medical devices. Medical devices that fall under the following definition [4] will be regulated as ‘drug’ under the DCA and MDR:
“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.”
Changes introduced by the Medical Device (Amendment) Rules, 2020
The first major amendment is introduction of a new chapter for registration of medical devices by their respective manufacturers and importers. The second is an exemption for the 37 categories of already regulated or notified medical devices from the requirement of registration introduced by the new chapter.
Requirement of registration
The manufacturers or importers of Medical Devices will be required to compulsorily register their medical devices with the Drugs Controller General of India (DCGI) before October 1, 2021. The DCGI will start accepting applications for registration through a dedicated online portal called ‘Online System for Medical Devices’ (established by Central Drugs Standard
Control Organisation) from April 1, 2020 (or from such later date by when the online portal is ready to accept applications). If an importer or manufacturer is unable to obtain registration for its medical device before October 1, 2021, then it will not be able to market and sell its medical device in India until a registration is obtained.
Penal consequence
The Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaint. In case the registrant fails to comply with any of the provisions of these rules, it may after giving the registrant an opportunity to show cause as to why an order for cancellation of registration should not be passed, by an order in writing stating the reasons thereof, cancel the registration number or suspend it for such period as it thinks fit either wholly or in respect of any of the medical devices to which it relates. [5]
Relaxation to obtain registration and license
The Government has given time to the medical device industry to transition into the regulatory framework and to obtain ISO 13485 certification, if not already obtained. The Government has relaxed the requirement to obtain registration and license for medical devices and other categories of medical devices for the following period:
- April 1, 2020 to October 1, 2021 (18 months) – Voluntary registration will be required to manufacture, import, distribute or sell Newly Notified Medical Devices [6]
- After October 1, 2021 – Mandatory registration will be required to import, manufacture, distribute or sell such medical devices [7]
- Before August 11, 2022 (30 months from notification) – License will be required to manufacture, import, distribute or sell Class A (low risk) or Class B (medium risk) medical devices [8]
- Before August 11, 2023 (42 months from notification) – License will be required to manufacture, import, distribute or sell Class C (moderate high risk) and Class D (high risk) medical devices as well [9]
Exemption for devices regulated or proposed to be regulated but notified before February 11, 2020
As indicated earlier, the 37 categories of medical devices regulated or notified before the date of MDR Amendment i.e. February 11, 2020, will not be affected by this amendment and therefore will not be required to obtain registration.
Consequences of not obtaining license before deadline
If an importer or manufacturer of a Medical Device fails to obtain a license until October 1, 2021, then it will have to cease import or manufacture of said medical device until such time the registration is obtained [10]. Manufacture and sale of the devices without a valid license as prescribed under the MDR will result in criminal prosecution which includes imprisonment (for not less than three years, extendable up to five years) and fine which shall not be less than Rs 1 lakh or three times the value of drug confiscated [11].
The effect of the amendment
The new Rules 2020 are being introduced to ensure that every medical device, either manufactured in India or imported, have quality assurance before they can be distributed / sold in the market. Further, a large number of commonly used medical items including hypodermic syringes and needles, cardiac stents, perfusion sets, catheters, orthopaedic implants, bone cements, lenses, sutures, internal prosthetic replacements etc. are covered under the new rules. The timeline for licensing and registration prescribed for medical devices as well as the risk-based categorised devices shall provide a breather for pharmaceutical companies. It gives a wider scope to test and modify such devices, which fall under the ambit of the new definition, post- introduction upon the relevant market.
References:
- S.O. 648(E) dated 11.02.2020_ Medical Device Definition
- G.S.R. 102(E)_dated 11.02.2020_ Registration of certain medical devices
- Amendment inserting Annexure to Eight Schedule under Rule 19A
- Section 3 (b) (iv), Drugs and Cosmetics Act, 1940
- Rule 19 E, The Medical Devices (Amendment) Rules, 2020
- Proviso to Rule 19 A (2), the Medical Devices (Amendment) Rules, 2020
- Ibid
- Amendment inserting S No. 7 to Eighth Schedule of the Medical Devices Rule, 2017
- Ibid
- Rule 85 of the Drugs and Cosmetics Rules, 1945
- Section 27 (b) (ii) of the Drugs and Cosmetics Act, 1940
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