RGN Medical
RGN Medical is a provider within the tga_sponsor_au directory, offering services related to the Military Health System (MHS). They are associated with the U.S. Department of Defense's health initiatives.
RGN Medical is listed as a provider within the tga_sponsor_au directory. The organization is associated with the U.S. Department of Defense's Military Health System (MHS), a large and complex healthcare institution responsible for providing health services to uniformed service members, military retirees, and their families. The MHS operates through both direct care at military hospitals and clinics, and private sector care. Its mission is to enable the Department of Defense to provide medically ready and ready medical forces by improving the health of all those entrusted to its care. The MHS aims to be a world role model for integrated military health and readiness, delivering technology-enabled, innovative, and military service-focused care. The website evidence indicates a strong connection to official U.S. government health information, specifically the health.mil domain, which is an official website of the United States government. This suggests RGN Medical's operations or focus align with the MHS's objectives and service delivery.
About
**Who they are**
RGN Medical is a specialized consultancy focused on navigating the Australian therapeutic goods regulatory landscape. They assist businesses in understanding and complying with the requirements set forth by the Therapeutic Goods Administration (TGA).
**Expertise & scope**
* TGA Sponsor services for Australian market entry
* Guidance on TGA registration and compliance pathways
* Support for Australian medical device regulations
**Reputation / proof points**
* Focus on the Australian market and TGA requirements
RGN Medical is a specialized consultancy focused on navigating the Australian therapeutic goods regulatory landscape. They assist businesses in understanding and complying with the requirements set forth by the Therapeutic Goods Administration (TGA).
**Expertise & scope**
* TGA Sponsor services for Australian market entry
* Guidance on TGA registration and compliance pathways
* Support for Australian medical device regulations
**Reputation / proof points**
* Focus on the Australian market and TGA requirements
Additional information
Engaging RGN Medical for TGA sponsorship involves understanding the specific requirements for bringing medical devices to the Australian market. Their services are designed to streamline the process of compliance with the Therapeutic Goods Administration (TGA). Buyers should be prepared to provide detailed information about their medical devices, including technical specifications and intended use, to facilitate the sponsorship and registration process. The engagement typically focuses on ensuring all documentation and procedures meet Australian regulatory standards.
Key Highlights
Certifications & Trust Signals
-
Focuses on TGA compliance for therapeutic goods.
Source
“TGA Compliance”
Buyer Snapshot
Best for
- Companies seeking TGA sponsorship for medical devices
- Businesses new to the Australian therapeutic goods market
How engagement typically works
- Consultative approach to regulatory requirements
- Process-driven compliance support
Typical deliverables
- TGA sponsorship facilitation
- Regulatory compliance guidance
- Assistance with TGA registration processes
Good to know
- Best when focused on Australian market entry for medical devices
HQ:
Adelaide, US
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, Orthopedics, Implants
Portfolio:
1-5
Onboarding time:
10–14 days
Pricing model:
Retainer
Starting from:
AUD 3,000
Included services:
ARTG inclusion application preparation and submission, Sponsor address and labeling review, Annual ARTG charge reminders and continuity planning, eBusiness Services account setup support
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
Australian Entity State:
AU
Additional tga_sponsor_au Details
Supports Artg
Yes
Onboarding Steps
Manages TGA registration process for overseas manufacturers.
