INTRODUCTION

The regulatory framework governing medical devices in India currently comprises the Drugs and Cosmetics Act, 1940 (“Act”) and the Medical Device Rules, 2017 (“Rules”). Medical devices, as defined more clearly within the purview of the Rules, encompass substances designed for in-vitro diagnosis, surgical dressings, bandages, staples, sutures, ligatures, blood collection bags, contraceptives, disinfectants, and insecticides, among other substances as notified.¹To ensure the quality and safety of medical devices, they are registered with the relevant licensing authorities.² The registration of medical devices is necessary to ascertain that they have passed rigorous tests and evaluations in accordance with applicable standards of safety and efficacy. It also helps in the traceability of manufacturers, importers, and distributors dealing with medical devices. Furthermore, if the medical device is not registered, the manufacturer or the importer would be liable to penal liabilities under the Act.³

To streamline and facilitate regulatory and registration processes, the central government has embarked on an ambitious task of consolidating regulatory approvals into a singular platform, denoted as the National Single Window System (“NSWS”) portal.⁴ The directorate general of health services, operating through the Central Drugs Standard Control Organisation (“CDSCO”), has introduced the shift of registration for notified bodies for medical devices and licenses for the import and manufacture of medical devices to the NSWS portal.⁵ This transition, communicated through a notice⁶ issued on 1 January 2024, marks a complete departure of license applications for the import and manufacture of medical devices from the previous CDSCO portal, also known as the SUGAM portal, with the new NSWS portal affecting the acceptance of the stated applications in the notice from the same date. However, it is pertinent to note that applications received before this date shall be entertained on the CDSCO portal only.

APPLICATIONS INCLUDED ON THE NSWS PORTAL

The NSWS portal was initially introduced as an investment clearance cell during the 2020 budget speech⁷ and aims to serve as a singular digital platform guiding investors through the identification of applicable approvals and their application processes.⁸ This platform aims to integrate different agencies and streamline the application and regulatory processes. Before the release of the notice, importers and manufacturers of medical devices were able to utilise this portal for other regulatory approvals and applications.⁹

The notice mandates the notified bodies to apply for the certificate of registration on the NSWS portal. A notified body refers to an institute, organisation, or body corporate that is competent to carry out auditing of manufacturing sites of certain medical devices to ensure that they conform with specified standards.¹⁰ The application for the registration of notified bodies is made through Form MD-01 as provided in the Rules,¹¹ which must be furnished along with the list of documents provided in the Rules. 

The application for a license to manufacture or import medical devices for clinical investigations, tests, evaluations, examinations, demonstrations, or training has also been included on the NSWS portal. The application for the license to manufacture medical devices is made through Form MD-12 and the application to import medical devices is made through Form MD-16 as provided in the Rules.

In continuation of the notice, CDSCO launched additional forms on the NSWS portal, effective from 16 January 2024. Certain forms under the New Drugs and Clinical Trials Rules, 2018 have also been launched on the NSWS portal. It is pertinent to note that the notice clarifies that the SUGAM portal will be disabled from 10 February 2024 onwards. 

CONCLUSION

The pivotal shift from a sector-specific registration floor to a nationalised one-stop platform indicates the central government’s commitment to promoting the ease of doing business and attracting investment. The envisaged transition of medical device-related registrations, compliances, and approvals to a single platform enhances user convenience, facilitates compliance, and optimises the registration and regulatory processes. The development of a collaborative portal for regulators would enhance the platform’s efficacy in line with its intended purpose.

[1] Rule 2(zb), Medical Device Rules, 2017.
[2] Rule 19A, 19B, 19C & 19D, Medical Device (Amendment) Rules, 2020.
[3] Sections 27(c), 27(d) & 31, Drugs and Cosmetics Act, 1940.
[4] NSWS Portal <https://www.nsws.gov.in/>.
[5] CDSCO portal <https://cdscomdonline.gov.in/NewMedDev/Homepage>
[6] CDSCO notice dated 1 January 2024. 
<https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTE%3D>
[7] ‘Single Window System’, Ministry of Commerce and Industry dated 8 December 2021.
 <https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1779399>;
[8] ‘e-INVESTMENT’, Ministry of Commerce and Industry dated 23 March 2022.
 <https://pib.gov.in/PressReleasePage.aspx?PRID=1808809#:~:text=Setting%20up%20of%20an%20Investment,at%20Centre%20and%20State%20level>
[9] Central Approvals, NSWS Portal. <https://www.nsws.gov.in/portal/approvalsandregistrations>
[10] Rule 13(1), Medical Device Rules 2017.
[11] Rule 13(5), Medical Device Rules 2017.