Before any rules were notified for medical devices, they were being governed solely by the dated and redundant Drugs and Cosmetics Act, 1940 with no specific provisions or aspects pertaining to the regulation of medical devices in India.
A need was felt to bring medical devices under a specific rules with an important motive of encouraging the ‘Make in India’ drive of the Government of India since these Rules provide for an extremely systematic and flexible compliance structure to be followed to acquire licenses for the manufacture of medical devices. Such provisions are sure to embolden the progression and growth of the medical devices industry in the nation.
The Medical Devices Rules, 2017 (the Rules) were notified by the Ministry of Health and Family Welfare on January 31, 2017 and were brought into effect from January 01, 2018.
These Rules have been framed in conformity with the Global Harmonisation Task Force framework and conform to best international practices. The International Medical Device Regulators Forum was started in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.
The said Rules were made applicable in the following manner :
“Application.— These rules shall be applicable in respect of,-
(i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
(iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);”
The Central Drugs Standard Control Organisation (Medical Devices and Diagnostic Division) has released a set of Frequently Asked Questions for creating public awareness with regard to the Rules that can be accessed on https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/digosfaq19.pdf.
The Medical Devices (Amendment) Rules,2020
On February 11, 2020 the Ministry of Health and Family Welfare, after consultation with the Drugs Technical Advisory Board notified to amend the Medical Devices Rules, 2017 and specified that these rules may be called the Medical Devices (Amendment) Rules, 2020 and shall come into force on April 1, 2020.
Chapter IIIA has been added in the Medical Devices Rules, 2017 which requires all devices notified under Section 3(b)(iv) of the Drugs and Cosmetics Act, except the devices notified under Schedule Eight of the rules, to be registered under the provisions of Chapter IIIA of the Rules, as per the newly added Rules 19A to 19F.
The notification can be accessed at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OQ
Key features of the Amendment
1.The Medical Devices as specified under the Amendment shall be voluntarily registered for a period of 18 months from 1 April, 2020 with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation. Thereafter, the registration shall be made mandatory.
2.The manufacturer of a medical device shall be required to upload the information with regard to the details of the medical device for registration on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organisation. Such as the details of the manufacturing entity of the device, the certificate of compliance with respect to ISO 13485 and the duly signed undertaking by the manufacturer stating that the information furnished is true and authentic.
3.Those who import any medical device as per the amended Rules shall be required to furnish the basic details of the medical device as specified hereinabove, and in addition to the same shall be required to furnish the free sale certificate from country of origin and the details as specified in Rule 19D (2) (ii).
4.After uploading the aforementioned information on the “Online System for Medical Devices”, the manufacturer is required to furnish the registration number on the label of the medical device.
5.The Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints. The procedure to be followed by the Central Licensing Authority in case the registrant fails to comply with any provision of these rules is also provided by in the amendment.
6.A new list of Medical Devices has also been added in the form of an Annexure to the Rule 19A.
Definition of “Medical Devices”
According to the Definition Notification as notified in the Gazette Notification on February 11, 2020, the Ministry amended the definition of “medical devices” under Section 3(b)(iv) of the Drugs and Cosmetics Act, 2020 as follows:
“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. “
The notification can be accessed at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA
By virtue of these latest amendments, the Government has brought a very large domain of “medical devices” within the ambit of the Medical Devices Rules, 2017 and has ensured that they are brought within the regulatory framework defined and assembled under the said Rules.
Thereby the Government has attempted to strictly regulate compliance to provisions of these rules to further emphasise the object of the Act by giving primary importance to safeguard the people against sub-standard or defective medical devices which might prove to be extremely lethal.
The change in the Rules also means that the manufacturing companies shall ensure and invest in a proper mechanism to meet with all the compliances under the Rules to avoid any adverse action. Furthermore, the Rules also provide for specific procedural compliances to be met with by importers of Medical Devices.
This is sure to boost the economy by attracting the International market of medical devices to India and is sure to boost the ‘Ease of doing Business’ initiative of the Government of India especially in the current pandemic times when the entire world’s economy is witnessing a major shift in the gravitas of its supply chain and its manufacturing hubs.
That being said, it would be interesting to note how the Government shall be able to implement a fully working model to classify and regulate the vast gamut of the medical devices” under the Rules and at the same time ensure proper compliance therewith. If a proper regulatory framework can be established and put into motion within a short span of time, this amendment can prove to be an extremely beneficial legislation for the medical industry as well as the economy of the nation, in a whole.
For provisions applicable exclusively to importers of medical devices