NSWS is established by the Central Government with the objective to build a genuine Single Window System, which acts as a one-stop shop for all the approvals required by the investor and facilitates Ease of Doing Business. The scope of NSWS includes all the approvals/licenses/registrations/clearances as applicable.

In this regard, Invest India, through TCS, has developed the NSWS portal for CDSCO, which will be independent from the existing SUGAM portal or CDSCO MD Online portal.

Initially, the following three activities under the Medical Devices Rules, 2017, have been developed and will be made 'Live' on the NSWS portal w.e.f. 01.01.2024:

1. Application for grant of Certificate of Registration of a Notified Body - Form MD-01
2. Application for licence to manufacture medical devices for the purpose of clinical investigations, test, evaluation, examination, demonstration, or training - Form MD-12
3. Application for licence to import medical devices for the purposes of clinical investigations, test, evaluation, demonstration, or training - Form MD-16

In view of the above, it is requested that all concerned stakeholders henceforth should submit applications related to the above-mentioned three activities through the NSWS portal only, and the existing CDSCO MD Online portal for these activities will be disabled w.e.f. 15.01.2024.

How to Register on NSWS

Step 1: Access the Investor Login

• Hover your cursor over the "Login" button on the NSWS website.
• Select "Investor (Business) Login" from the dropdown menu.

Step 2: Sign In or Register

• For existing users: Enter your email address and password, then click on "Sign In" to access your account.
• For new users: Click on "Sign Up Now" to register a new account.

Step 3: Sign Up for a New Account

• Enter your Full Name, Email ID, Mobile Number, and Set Password.
• Click on "Verify" next to the Email and Mobile Number fields to receive an OTP (One-Time Password) for verification.
• Once verified, click on "Sign Up Now" to complete the registration process.

Step 4: Complete Registration

• Once the Email ID and Mobile Number are successfully verified, a green check mark will appear next to them.
• Click on "Sign Up Now" to complete the registration.
• Upon successful registration, users will be automatically logged into their NSWS account.

How to Create Business Profile on NSWS

Step 1: Selecting the Legal Entity Type

• After successful registration, you will be directed to "Select your legal entity type".
• Choose the appropriate legal entity type from the available options:
  • Incorporated Company (For businesses registered with CIN)
  • Limited Liability Partnership (LLP) (For LLPs with an LLPIN)
  • Sole Proprietor
  • Others
• If you are registering a new business entity, click on "None of these, I’m planning to register a new entity".
• If you are applying for Foreign Investment Approval, click "None of these, FDI in India" and refer to the "How to apply for Foreign Investment Approval" guide for more details.

Entity Type	Description
Incorporated Company	A legal entity registered under the Companies Act in India, having a valid CIN (Company Identification Number)
Limited Liability Partnership	A partnership incorporated in India under the Limited Liability Partnership Act, 2008, having a valid LLPIN (Limited Liability Partnership Identification Number)
Sole Proprietor	A single individual owning the entire business and being the sole recipient of all profits and bearer of all losses
Others	Any other kind of business establishment

Step 2: Enter Business Name and Proceed

• After selecting the appropriate legal entity type, enter your Business Name in the given field.
• Click on the "NEXT" button to proceed to the next step.

Step 3: Validate Your Permanent Account Number (PAN)

• Enter your Permanent Account Number (PAN) in the designated field.
• Click on "GET DETAILS" to fetch the PAN details from the system.
• After validation, proceed by clicking "NEXT".

Step 4: Verify PAN Details and Accept Declaration

• After fetching the PAN details, verify the 'Name on PAN Card' displayed on the screen.
• Accept the declaration stating that the details provided are associated with your company.
• Click on "NEXT" to proceed.

Step 2: Enter Business Address Details

• Fill in the postal and registered address of your business.
• Enter details such as Address Line 1, Address Line 2, Country, State, District, and PIN Code.
• Click on "NEXT" to proceed.

Step 3: Complete Business Profile

• Fill in the Authorized Signatory Details, including:
  • First Name, Middle Name, Last Name
  • Designation
  • Date of Birth
  • PAN of Authorized Signatory
  • Email Address and Mobile Number
  • Address details (Postal & Registered Address)
• Optionally, register your Digital Signature Certificate (DSC).
• Click "Save" to update the profile.

Contact Satori OCS Today

Ready to take the next step in navigating FDA regulatory controls for your medical device? Reach out to Satori OCS for expert guidance and support.

Contact Information:

• Email: satoriocs@gmail.com
• Phone: +91 98290 98077
• Website: www.satorics.com

Let us help you streamline your regulatory submission process and bring your medical device to market with confidence.