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. They specialize in 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.
* Providing tailored solutions for market entry in Australia and New Zealand.
* Acting as the Australian Sponsor for medical devices and IVDs, ensuring their details appear on product labelling or packaging.
* Managing and maintaining product registrations within the Australian market.
**Reputation / proof points**
* Act as Australian and New Zealand Sponsors.
Acrapack Regulatory Services (ACRA) are dedicated regulatory consultants and compliance guidance advisors for companies in the medical, lifescience, biotechnology, and healthcare industries. They specialize in 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.
* Providing tailored solutions for market entry in Australia and New Zealand.
* Acting as the Australian Sponsor for medical devices and IVDs, ensuring their details appear on product labelling or packaging.
* Managing and maintaining product registrations within the Australian market.
**Reputation / proof points**
* Act as Australian and New Zealand Sponsors.
Additional information
Acrapack Regulatory Services focuses on simplifying the process of medical device and IVD registration in Australia and New Zealand. They serve as the essential Australian sponsor, managing all compliance requirements and facilitating market entry. Their services are designed to provide comprehensive management of product registration compliance and quality system implementation, offering tailored solutions to meet specific market visions.
Key Highlights
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Acrapack Regulatory Services acts as an Australian Sponsor for medical devices and IVDs.
Source
“ACRA regulatory services as your Australian medical device sponsor”
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They offer comprehensive management of product registration compliance and quality system implementation.
Source
“We offer full comprehensive management of your product registration compliance, quality system implementation”
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Acrapack provides 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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Established as a dedicated regulatory consultant and compliance guidance advisor.
Source
“Acrapack are dedicated regulatory consultants and compliance guidance advisers”
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
- Acting as a direct representative for market entry.
- Providing tailored compliance solutions.
Typical deliverables
- Australian Sponsor services.
- Management of product registration compliance.
- Quality system implementation guidance.
Good to know
- Best when requiring a dedicated Australian sponsor to manage regulatory affairs and market access.
HQ:
Gold Coast, AU
Languages:
English
Timezones:
Australia/Sydney
Claim status:
Listed
Services & Capabilities
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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 website mentions requesting a proposal, a quote, or sending an enquiry about representation.
