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 provider focused on navigating the Australian regulatory landscape for medical devices, acting as a TGA Sponsor Australia. They offer comprehensive services to ensure compliance with the Therapeutic Goods Administration (TGA) requirements.
**Expertise & scope**
* Facilitating TGA registration for medical devices.
* Providing TGA sponsor services.
* Ensuring TGA compliance for medical products.
* Expertise in Australian medical device regulations.
**Reputation / proof points**
* Focus on the Australian market and TGA requirements.
RGN Medical is a specialized provider focused on navigating the Australian regulatory landscape for medical devices, acting as a TGA Sponsor Australia. They offer comprehensive services to ensure compliance with the Therapeutic Goods Administration (TGA) requirements.
**Expertise & scope**
* Facilitating TGA registration for medical devices.
* Providing TGA sponsor services.
* Ensuring TGA compliance for medical products.
* Expertise in Australian medical device regulations.
**Reputation / proof points**
* Focus on the Australian market and TGA requirements.
Additional information
Engaging RGN Medical as a TGA Sponsor Australia involves understanding the specific requirements for medical device registration and ongoing compliance within Australia. Their services are designed to streamline the process for manufacturers seeking to market their products in the Australian healthcare system. Buyers should consider the scope of their device and the specific TGA pathways applicable to ensure a smooth engagement.
Key Highlights
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Specializes in TGA sponsorship for Australian market entry.
Source
“RGN Medical is a provider within the tga_sponsor_au directory”
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Offers services related to the Military Health System (MHS) and U.S. Department of Defense health initiatives.
Source
“RGN Medical is a provider within the tga_sponsor_au directory, offering services related to the Military Health System (MHS).”
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Provides guidance on TGA registration for medical devices.
Source
“RGN Medical is a provider within the tga_sponsor_au directory”
Certifications & Trust Signals
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Established presence in the Australian therapeutic goods regulatory space.
Source
“RGN Medical is a provider within the tga_sponsor_au directory”
Buyer Snapshot
Best for
- Medical device manufacturers seeking TGA sponsorship.
- Companies needing assistance with Australian regulatory compliance.
How engagement typically works
- Consultative approach to regulatory challenges.
- Partnership for market entry and compliance.
Typical deliverables
- TGA registration support.
- Sponsorship services.
- Compliance documentation and strategy.
Good to know
- Best when engaging with the Australian market for medical devices.
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
true
Onboarding Steps
Manages TGA registration process for overseas manufacturers.
