National Single Window System (NSWS) – The Central Drugs Standard Control Organization (CDSCO) of India on January 01, 2024, published a notice talking about the release of a new portal called National Single Window System (NSWS). The National Single Window System (NSWS) as a concept has been introduced to ease the process of applying for regulatory approvals and registrations in India through a single location with an objective as below – (1) To help Medical Device Manufacturers registering in India have a single-window mechanism by integrating the services provided by various Central Ministries, Departments, and State Governments and (2) Provide a one-stop-shop for procuring pre-establishment and pre-operation approvals, permits and clearances required to establish a business in India
Why the National Single Window System (NSWS) Matters for Medical Device Registration
This portal is important for every Medical Device Manufacturer looking to register their medical devices in India along with their Indian Agent. It can be created by an Indian Company and initially the transition would be for the following three activities under the Medical Devices Rules, 2017 to be made ‘Live’ on National Single Window System (NSWS) portal w.e.f. 01.01.2024:-
- Form MD-01: Application for grant of Certificate of Registration of Notified Body
- Form MD-12: Application for license to manufacture medical devices for the purpose of clinical investigations, test, evaluation, examination, demonstration
- Form MD-16: Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration
Key Features and Initial Activities on the National Single Window System (NSWS)
- Identification of Required Approvals: The ‘Know Your Approvals (KYA)’ feature allows medical device companies to easily determine specific approvals needed, including those related to MD-15 regulations and the newly introduced functionalities.
- Application Submission :An Indian Agent can make a submission directly on the NSWS Portal
- Tracking and Status Updates: Real-time updates on the NSWS portal for a submitted application
- Review Legal Form: The user can review the legal form submitted
- Application Preparation and Submission: The portal provides detailed checklists to help prepare the necessary documents helping Medical Device Manufacturers looking to register their devices in India
The Impact of National Single Window System
(NSWS) on India’s Medical Device Industry
India’s demand for medical devices is projected to reach $50 billion by 2030. The annual demand for medical devices in India is estimated at around $12 billion, with imports of over 60 per cent. Streamlining the regulatory approval process, import requirements, State specifications etc will help Medical Device Manufacturers looking to register their Medical Devices in India have an overview of the exact regulations and compliances. This will also streamline operations in India enabling the Nation to cope up with the increasing demands.
Morulaa HealthTech works with Medical Device Manufacturers in order to support them in their Product Registration in India. Having an account with the NSWS portal, we will help you navigate the requirements, provide the necessary checklists to fill the MD-14 form etc to make an application to the government. For more information on how Morulaa HealthTech can assist you in navigating the medical device market for registration and market entry, please reach out to us on [email protected] or visit our website at www.morulaa.com.