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 TGA Sponsor Australia provider specializing in navigating the Australian therapeutic goods regulatory landscape. They focus on assisting companies with their TGA obligations.
**Expertise & scope**
* Facilitating TGA sponsorship for medical devices and other therapeutic goods.
* Managing regulatory compliance requirements within Australia.
* Supporting the process for Australian medical device registration.
* Providing expertise in TGA compliance matters.
**Reputation / proof points**
* Focus on the Australian market and its specific regulatory framework.
RGN Medical is a TGA Sponsor Australia provider specializing in navigating the Australian therapeutic goods regulatory landscape. They focus on assisting companies with their TGA obligations.
**Expertise & scope**
* Facilitating TGA sponsorship for medical devices and other therapeutic goods.
* Managing regulatory compliance requirements within Australia.
* Supporting the process for Australian medical device registration.
* Providing expertise in TGA compliance matters.
**Reputation / proof points**
* Focus on the Australian market and its specific regulatory framework.
Additional information
Engaging RGN Medical as a TGA Sponsor involves understanding their role in representing overseas manufacturers to the Therapeutic Goods Administration (TGA). This typically includes managing the ARTG (Australian Register of Therapeutic Goods) entries, ensuring ongoing compliance with Australian regulations, and acting as the primary point of contact for TGA communications. Buyers should consider the scope of services required, such as initial registration, post-market surveillance, or variations to existing entries, to ensure alignment with RGN Medical's offerings.
Key Highlights
Certifications & Trust Signals
-
Focuses on TGA compliance for therapeutic goods.
Source
“TGA Compliance”
Buyer Snapshot
Best for
- Overseas manufacturers seeking TGA sponsorship in Australia
- Companies needing assistance with Australian medical device registration
How engagement typically works
- Acting as the official TGA Sponsor
- Providing regulatory compliance support
Typical deliverables
- ARTG application management
- TGA compliance guidance
- Regulatory representation
Good to know
- Best when the primary need is Australian market access and regulatory representation.
HQ:
Adelaide, US
Languages:
English
Timezones:
Australia/Sydney
Claim 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.
