Acrapack Regulatory Services (ACRA)
Acrapack Regulatory Services
Acrapack Regulatory Services simplifies medical device and IVD registration in Australia and New Zealand. They act as your Australian sponsor, managing compliance and market entry.
Acrapack Regulatory Services specializes in guiding companies through the complex process of registering medical devices and In Vitro Diagnostics (IVDs) in Australia and New Zealand. As an experienced Australian sponsor, Acrapack ensures your product labeling and packaging meet regulatory requirements, confidently representing your company and maintaining your registrations. They offer comprehensive management of product registration compliance, quality system implementation, and expert regulatory guidance. Acrapack provides tailored solutions to help you achieve your market visions, whether locally or globally. Their services are designed for companies in the medical, life science, biotechnology, and healthcare industries seeking to navigate the Australian and New Zealand regulatory landscapes. Acrapack is dedicated to resolving your regulatory concerns and providing focused support to ensure successful market access. They understand the nuances of the Australian medical device and IVD market, offering peace of mind and efficient management of your compliance needs.
About
**Who they are**
Acrapack Regulatory Services (ACRA) are dedicated regulatory consultants and compliance guidance advisors for companies in the medical, lifescience, biotechnology, and healthcare industries, focusing on Medical Devices and Invitro Diagnostics (IVDs).
**Expertise & scope**
* Full comprehensive management of product registration compliance.
* Quality system implementation.
* Expert guidance and resolution of regulatory concerns.
* Tailored solutions for market entry in Australia and New Zealand.
* Act as an Australian Sponsor, managing and maintaining registrations.
**Reputation / proof points**
* Act as Australian Sponsor for medical devices and IVDs.
* Act as New Zealand Sponsor for medical devices and IVDs.
Acrapack Regulatory Services (ACRA) are dedicated regulatory consultants and compliance guidance advisors for companies in the medical, lifescience, biotechnology, and healthcare industries, focusing on Medical Devices and Invitro Diagnostics (IVDs).
**Expertise & scope**
* Full comprehensive management of product registration compliance.
* Quality system implementation.
* Expert guidance and resolution of regulatory concerns.
* Tailored solutions for market entry in Australia and New Zealand.
* Act as an Australian Sponsor, managing and maintaining registrations.
**Reputation / proof points**
* Act as Australian Sponsor for medical devices and IVDs.
* Act as New Zealand Sponsor for medical devices and IVDs.
Additional information
Acrapack Regulatory Services emphasizes their role as an Australian Sponsor, highlighting that the sponsor's details must appear on product labelling or packaging. They possess a deep understanding of the Australian medical device and IVD market, confidently representing clients and managing their registrations. For those seeking to enter the Australian market, Acrapack offers to represent companies as their Australian sponsor, providing tailored solutions to achieve market visions.
Key Highlights
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Acts as an Australian Sponsor, managing and maintaining medical device and IVD registrations.
Source
“ACRA regulatory services understand the Australian medical device and IVD market and confidently represent you and manage and maintain your registrations.”
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Provides comprehensive management of product registration compliance for medical devices and IVDs.
Source
“We offer full comprehensive management of your product registration compliance, quality system implementation, expert guidance, resolution of your regulatory concerns”
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Offers tailored solutions for market entry in Australia and New Zealand.
Source
“providing focused tailored solutions to achieve your market visions locally and globally.”
Certifications & Trust Signals
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Dedicated regulatory consultants and compliance guidance advisors.
Source
“Acrapack are dedicated regulatory consultants and compliance guidance advisers to companies in the medical, lifescience, biotechnology and healthcare industries”
Buyer Snapshot
Best for
- Companies seeking an Australian Sponsor for medical devices and IVDs.
- Businesses needing assistance with product registration compliance in Australia and New Zealand.
How engagement typically works
- Comprehensive management of regulatory compliance.
- Tailored solutions for market entry.
Typical deliverables
- Australian Sponsor services.
- New Zealand Sponsor services.
- Product registration management.
- Quality system implementation guidance.
Good to know
- Best when requiring local representation and regulatory expertise for the Australian and New Zealand markets.
HQ:
Gold Coast, AU
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, IVD
Portfolio:
1-5
Onboarding time:
3–30 days
Pricing model:
Per project
Starting from:
AUD 1,800
Included services:
ARTG inclusion application preparation and submission, Change notification and variation assessment, eBusiness Services account setup support, TGA device classification and grouping
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Australian Entity State:
AUSTRALIA
Recall Vigilance Support:
No
Fsca Recall Support:
No
Additional tga_sponsor_au Details
Supports Artg
true
Onboarding Steps
The provider offers to represent companies and manage/maintain their registrations, suggesting an onboarding process would be initiated upon contact for a proposal, quote, or enquiry.
