India Changes Medical Device Application Processing System

India’s New Online Application Processing System

On January 1, 2024, the Central Drug Standard Control Organisation (CDSCO) released a notice (ref. IT-13011(11)/1/203 link, pdf) regarding use of the Nation Single Window System (NSWS) portal. India’s application processing system is changing to the NSWS, which will be replacing the old processing system, CDSCO MD Online. Initially, only three activities under MDR 2017 were developed and made operational on the NSWS portal January 1, 2024.
However, on January 16, 2024, the CDSCO expanded upon its activities and added more forms (link, pdf). The added forms are as follows:

1. Form MD-01 – Application for grant of Certificate of Registration of a Notified Body.
2. Form MD-12 – Application for grant of license to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training.
3. Form MD-16 – Application for grant of license to import medical device for purpose of clinical investigations or test or evaluation, or demonstration or training.
4. Form CT-10 – Request for authority to manufacture new or experimental drugs for use in bioavailability or bioequivalence tests, clinical trials.
5. Form CT-12 – Request for approval to create a formulation with an unapproved active pharmaceutical ingredient for use in analysis, bioequivalence, clinical trials, or other studies involving bioavailability.
6. Form CT-13 – Application for permission to manufacture unapproved active pharmaceutical ingredients for clinical trials, formulation development, analysis, testing, and bioavailability and bioequivalence research.
7. Form CT-16 – Request for permission to import new or experimental drugs for testing, analysis, and inspection purposes, as well as for use in bioavailability or bioequivalence studies and clinical trials.
8. Form 12 – Application for license to import drugs for purpose of examination, test or analysis.

In the future, we envisage that all applications to CDSCO including Form MD-15 (application for a medical device Import License) will be processed through NSWS. Critically, the implementation of single-window pathways is expected to increase operation efficiencies, especially as the number of covered regulatory pathways increases to include import and manufacturing licenses for medical devices.

What to Expect from the NSWS

The National Single Window System (NSWS) is a digital platform that was launched in September of 2021 and is managed by the Department for Promotion of Industry and Internal Trade (DPIIT) in the Ministry of Commerce and Industry. India’s change of application processing system to the NSWS is mainly to centralize and streamline all the government approvals and clearances required of businesses. All states, union territories and 32 central government departments are to integrate with the National Single Window System (NSWS) by December 2024.

With NSWS, applicants can apply for various licenses under multiple ministries from a single platform/window. Furthermore, this means that sometime in the future we may be able to get the import license from CDSCO for a device x, BIS registrations for the battery/monitor/adaptor of this device x, its environment related approvals for plastic packaging, e-waste, battery waste; wireless frequency approvals – by applying under one portal only.

Pre-NSWS

Currently, licenses and registrations are being issued by a plethora of regulatory organizations in India, under multiple regulations, implemented by several ministries/ departments, including but not limited to: Bureau of Indian Standards (BIS), Atomic Energy Regulatory Board (AERB), Pre-Conception Pre-Natal Diagnostic Testing (PCPNDT) state departments, Department of Telecommunications Equipment Type Approval (DoT ETA), Central Pollution Control Board (CPCB) e-waste, plastic waste and battery waste. Thus, we can imagine how beneficial it will be to successfully achieve a genuine single window for all medical device related licenses and registrations India.

A unified single window has been a long-standing request of the Indian medical device industry and the present notification from the CDSCO is a welcome step in the right direction to increase the ease of doing medical device business in India.

Who Will Have Access

Firstly, manufacturers, importers, or distributors of medical devices that wish to submit applications through the NSWS must declare their legal entity and can be an Indian company or individual/sole proprietor or even entity with Foreign Direct Investment (FDI) in India or planning to start a legal entity. The Corporate Identification Number/Limited Liability Partnership Identification number or business name is required. Please refer to pages 4-5 of the ref. IT-13011(11)/1/203 (link, pdf) for a user’s guide on how to apply for NSWS access.

Cost

The standard fee for the form/license mechanism as listed under the individual Laws will continue to be applicable. According to the Medical Device Rules 2017, NSWS currently is applicable only to some forms – one of them is the Form MD-16.

The Fee for Import license for test, evaluation or demonstration or training for each distinct medical device in Form MD-16 is $100 USD and this will continue to be the same – only the application will be from the NSWS and not the existing portal.

Scope

It is important to understand that the scope of NSWS is beyond just medical devices or the Medical Device Rules 2017 or the CDSCO. Ambitiously, the NSWS is forecasted to be one single window for ALL approvals across ALL Ministries and Departments.

While the CDSCO will continue to be most relevant in our line of business, other departments under multiple sectors and ministries are also transitioning to the NSWS.

Finally, the NSWS will eventually completely replace the current on-line portal operated by India’s Central Drugs Standard Control Organization (CDSCO), which has been in place since January 2016. Under this portal, applications were submitted in-person in hard copy format (two full copies).