With the prevalence of COVID-19 and the consequent lockdown, various entities, Small Scale Industries, MSMEs, Start-ups have entered into the manufacturing of PPE kits, masks, medical gloves, body bags, cover-alls, boot covers, etc. which aided India to increase its manufacturing capacity as a response to the pandemic. However, for manufacturing and supply of the aforementioned items are now categorized as Medical Devices owing to the amendment in the Medical Devices (Amendment) Rules, 2020. Consequently, the manufacturers will be obligated to get registration for the same under the mandate of the Medical Devices Rules, 2017.
Medical Devices are defined and provided under the definition of Section 3(b)(iv) of Drugs & Cosmetics Act, 1940, which are specified by the Central Government through notifications. Furthermore, the Drugs & Cosmetics Act, 1940 and rules, thereunder, apart from regulating the manufacturing of medicines and cosmetics, it also specifies specific provisions relating to regulating and streamlining the manufacturing process of medical devices. Significantly, for better regulation of the standards of medical devices, the Central Government notified the Medical Devices Rules, 2017. The Medical Device Rules 2017, with the purposes of regulating Clinical investigations, manufacturing, import, sale and distribution of Medical Devices. The said Rules have also done risk based classification of the Medical Devices into:
Class A devices: Low Risk
Class B devices: Low Moderate Risk
Class C devices: Moderate High Risk
Class D devices: High Risk.
Furthermore, specific parameters are laid down for assessing and classifying the medical devices including in vitro diagnostic devices.
On 11.02.2020, the Central Government issued two notifications namely S.O. 648(E) and GSR 102(E):
- The Central Government widened the scope of definition of Medical Devices vide its notification dated 11.02.2020, effective from 01.04.2020
- Notified amendment in the Medical Device Rules, 2017, to be effective from 01.04.2020.
As per the new S.O. 648(E), from April 1, 2020, all medical devices including all apparatus, material, appliance, etc. for any intended purpose, invasive or non-invasive, used directly or indirectly in human or animal has been included under the definition of Medical Devices, over and above the already 37 notified categories of Medical Devices. Thus, it implies that all medical devices, including face masks or any other device even remotely used for medical purposes shall be included under the definition of Medical devices.
Significantly, as of now (until February 11, 2020), only 37 categories of medical devices were regulated or notified as drugs. From April 1, 2020, the medical devices that fall under the following definition will be regulated as "drug" under the Drugs and Cosmetics Act, 1940 (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 ?
- Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
- Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- Investigation, replacement or modification or support of the anatomy or of a
- physiological process;
- Supporting or sustaining life;
- Disinfection of medical devices; and
- Control of conception"
Furthermore, on 11.02.2020 itself, the Ministry issued a GSR 102(E) amending the Medical Devices Rules 2017. So now under the amended Rules, firstly, it is stated that all medical devices shall have to be mandatorily registered with CDSCO and for the said purposes the amendment has specially adding Chapter IIIA for the said purpose specifying the procedure for registration of certain devices. Secondly, it also added that all medical devices are exempted from the applicability of Medical Devices rules except those mentioned in Annexure of Eighth Schedule (which are the pre-existing medical devices as on the date of 10.02.2020), provided they are registered as per Chapter IIIA. However, such exemption has been given a specific time period, like for Class A devices (which will include masks) and Class B (medium risk) it is 30 months and 42 months for Class C (moderately high risk) and Class D (high risk) devices. In other words, the medical devices regulated or notified before the date of Medical Devices Rules Amendment i.e. February 11, 2020, which are embodied in the Annexure of Schedule 8 i.e. the pre-existing notified medical devices as on 10.02.2020, will not be affected by this amendment and therefore will not be required to obtain registration under Chapter IIIA. However, other medical devices, which are newly defined shall be required to register as per Chapter IIIA.
Significantly, these amendments will squarely be also applicable for N-95 or surgical masks manufacturers, face shields, medical gloves, etc. PPEs cover alls, or other Class A medical devices which were earlier not notified, so that they get time to transition and get registration under Drugs and Cosmetics Act as Medical Devices Rules, 2017. With the prevalence of COVID-19, various start-ups, MSMEs, SSIs have entered into the business of manufacturing of masks, face shields, medical gloves, PPE coveralls, etc. However, now with the amendment of the Medical Devices Rules, now that all such articles are categorized as medical devices, it will be incumbent on all manufacturers of masks or other PPE components to get registration of such articles in terms of Chapter IIIA of the Medical Devices Rules, 2017 as per the following timelines:
- April 1, 2020 to October 1, 2021 (18 months) - Voluntary registration will be required to manufacture, import, distribute or sell Newly Notified Medical Devices
- From October 1, 2021 - Mandatory registration will be required to import, manufacture, distribute or sell such newly notified medical devices
- From August 11, 2022 (30 months from notification) - In the absence of registration, the manufacturers will not be allowed to manufacture, import, distribute or sell Class A (low risk) or Class B (medium risk) medical devices
- From August 11, 2023 (42 months from notification) - In the absence of registration, the manufacturers will not be allowed to manufacture, import, distribute or sell Class C (moderate high risk) and Class D (high risk) medical devices.
The Central Drug Standards Control Organisation has also issued an advisory note dated 22.05.2020 specifying that the manufacturers of PPE coverall may get voluntary registration of their articles with CDSCO and also specified labs which are recognized by the Ministry of Textiles for the testing of the same. Significantly, for approval and certification of the aforementioned Class A medical devices, the manufacturers will be required to adhere to the applicable BIS standards, ISO standards and get the requisite certification by the approved Testing Agencies. After the certification, the manufacturers may get registration with CDSCO as per the applicable norms as specified under Chapter IIIA of the Medical Devices Rules, 2017.
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