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  • Gn-24-r1.1 Guidance On The Change Of Registrant

Get Gn-24-r1.1 Guidance On The Change Of Registrant

May 2014MEDICAL DEVICE GUIDANCE GN24: Guidance on the Change of Registrant Revision 1.1MEDICAL DEVICE GUIDANCEMAY 2014PREFACE R1.1 This document is intended to provide general guidance. Although wehave.

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How to use or fill out the GN-24-R1.1 Guidance On The Change Of Registrant online

This guide provides clear, step-by-step instructions on filling out the GN-24-R1.1 form for the change of registrant of a registered medical device. It aims to support users at all levels of experience in completing the forms accurately online.

Follow the steps to fill out the GN-24-R1.1 form effectively.

  1. Use the ‘Get Form’ button to access the GN-24-R1.1 form and open it in the appropriate editor.
  2. Complete the Accepting Company section with the name, address, and contact information (telephone, fax, and email) of the newly appointed Registrant.
  3. Provide a duly completed and signed Change of Registrant Application Form, ensuring it includes all required information.
  4. Prepare the letter of authorization from the Product Owner on company letterhead, appointing the Accepting Company as the Registrant.
  5. Draft a letter from the Product Owner to HSA, including the effective date of the appointment, the list of applicable registered medical devices, and any necessary changes to the registered medical devices.
  6. Complete the Relinquishing Company Declaration Form, ensuring it is signed by a company director or senior officer.
  7. Review all provided information for accuracy, attach any additional documentation if necessary, and ensure signatures are included where required.
  8. Submit the completed form and all supporting documents via email or fax to the specified contact information.
  9. Upon submission, wait for the notification of the outcome from HSA regarding the application for the change of Registrant.

Complete your documents online today for a smooth transition of registrant!

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There are 3 classes of medical devices: Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs. Class II devices are intermediate-risk devices. Examples include computed tomography (CT) scanners or infusion pumps for intravenous medications.

This Act is the Healthcare Services Act 2020 and comes into operation on a date that the Minister appoints by notification in the Gazette.

Medical devices in Singapore are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). Singapore is a member of the Association of Southeast Asian Nations (ASEAN) and its regulatory system is based on the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010.

A wholesaler's licence allows the dealer to: supply a medical device by wholesale (including export) in Singapore. supply a medical device to a party for re- supply .

The electric wheelchair is an example of a Class 2 medical device. These devices, like all medical devices, are regulated by the Federal Drug Administration (FDA) and other standards organizations.

3 Basic Pathways to Medical Device Approval Pathway 1: Pre-market approval (PMA) ... Pathway 2: Pre-marketing notification (PMN): The 510(k) application. ... Pathway 3: The humanitarian device exemption (HDE)

Class A – this classification is for the lowest risk in vitro diagnostic devices. Most IVD devices in this category do not require a conformity assessment. Instead, they can be self-assessed. Class B – this classification is for medium risk in vitro diagnostic devices.

Prepare an application dossier including all required documentation as applicable to the registration route for submission to the HSA. Your Singapore Registrant submits the application electronically through the HSA's online registration system and pays the application and evaluation fees.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232