Print ARTG Certificate of Inclusion
Need a compliant path to print your ARTG Certificate of Inclusion for medical devices? Elexes helps manufacturers and sponsors navigate TGA requirements, confirm ARTG status, and align supporting documentation so Australian market access stays smooth, accurate, and audit-ready. Get expert guidance that reduces avoidable delays and keeps your regulatory records clear from application through certificate retrieval.
Our ARTG Certificate Services
Focused support for ARTG inclusion, TGA documentation, and submission readiness for medical device market access in Australia.
ARTG Inclusion
Support for preparing, reviewing, and managing ARTG inclusion requirements so your medical device can be legally supplied in Australia with accurate, defensible registration records.
TGA Documentation
Hands-on help aligning device descriptions, conformity evidence, essential principles documentation, and supporting records to TGA expectations for smoother certificate-related workflows.
Submission Readiness
Structured readiness assessments identify documentation gaps, classification issues, and compliance risks before ARTG submission or certificate retrieval activities begin.
Australia Market Access
Clearer ARTG Certificate Support
Printing an ARTG Certificate of Inclusion is simple only when the underlying registration is correct. Elexes helps medical device manufacturers and sponsors verify ARTG inclusion status, align TGA-facing documentation, and resolve issues that can slow Australian supply timelines. Our team supports the regulatory groundwork behind certificate access so your records are accurate, traceable, and ready for commercial, audit, and distributor needs.
Trusted By Manufacturers
Success Stories
See how regulatory support helps manufacturers move through ARTG requirements with greater confidence and fewer delays.
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!”
Kurt Sysock
“Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms”
Tom Birney
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.”
Diane Bryant
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!”
Kurt Sysock
“Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms”
Tom Birney
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.”
Diane Bryant
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!”
Kurt Sysock
“Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms”
Tom Birney
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.”
Diane Bryant
The Elexes Difference
Why Choose Elexes?
Manufacturers rely on Elexes for precise, end-to-end regulatory support across complex medical device pathways.
Deep Experience
50+ years of collective experience across TGA, FDA, EU MDR, and global device regulations.
TGA Alignment
We help align ARTG and TGA documentation to Australian requirements before avoidable deficiencies arise.
End-to-End
Support spans readiness, submission, approval, and post-market compliance for ongoing regulatory continuity.
Flexible Support
Project-based or embedded consulting gives manufacturers expert coverage without adding permanent headcount.
Meet The Elexes Team
Experienced regulatory specialists supporting complex device approvals.
Elexes Medical Consulting Pvt. Ltd. supports medical device manufacturers with practical regulatory and quality expertise across global markets, including Australia. The team helps companies navigate TGA requirements, ARTG inclusion pathways, technical documentation alignment, and broader market-entry obligations with a disciplined, evidence-based approach. Over the years, Elexes has become a trusted consulting partner for manufacturers seeking support from early regulatory planning through approvals and post-market compliance. With 50+ years of collective experience, the company combines regulatory, quality, and clinical insight to reduce submission risk, improve audit readiness, and keep projects moving efficiently. Its model is built around transparency, confidentiality, and measurable outcomes for medical device companies managing complex compliance demands.
250+ ProjectsSuccessful regulatory and compliance engagements completed.200+ Product TypesExperience across diverse medical device categories.90% Audit ClearanceStrong track record in inspection and audit readiness.
Frequently Asked Questions
How to get a TGA certificate?
To obtain a TGA-related certificate for a medical device, the device typically must first be properly included in the Australian Register of Therapeutic Goods (ARTG), with the correct sponsor and supporting conformity assessment evidence in place. Once inclusion is confirmed, the certificate can generally be accessed or printed through the relevant TGA systems. Accurate classification, documentation, and sponsor details are essential to avoid delays.
What is the Australian register of therapeutic goods?
The Australian Register of Therapeutic Goods, or ARTG, is the official database of therapeutic goods that can be lawfully supplied in Australia. For medical devices, ARTG inclusion shows that the device has gone through the applicable regulatory pathway and is linked to an Australian sponsor. It is a core part of TGA market access and ongoing compliance oversight.
Can I print an ARTG Certificate of Inclusion online?
Yes, in many cases the ARTG Certificate of Inclusion can be printed online once the device is successfully included and the authorized sponsor has access to the relevant TGA portal or records. However, printing the certificate does not replace the need for correct underlying registration data. If sponsor details, classification, or documentation are inaccurate, those issues should be resolved first.
Who can print the ARTG Certificate of Inclusion?
The Australian sponsor associated with the ARTG entry is typically the party authorized to access and print the Certificate of Inclusion. Manufacturers working from outside Australia usually rely on their sponsor arrangement for this step. It is important that sponsor information, device details, and ARTG records are current so the certificate reflects the correct legal supply status.
What information is needed before printing an ARTG certificate?
Before printing an ARTG certificate, you should confirm the ARTG entry number, device name, classification, sponsor details, and inclusion status. It is also wise to verify that supporting documentation remains aligned with the approved entry, especially if there have been design, labeling, software, or manufacturing changes. Clean records help prevent downstream issues during audits, distributor onboarding, or market checks.
What if my device is not yet included in the ARTG?
If the device is not yet included in the ARTG, a certificate cannot be printed because legal inclusion has not been granted. The next step is to determine the correct TGA pathway, confirm classification, prepare conformity assessment evidence, and submit a complete application through the appropriate sponsor arrangement. Readiness reviews can help identify gaps before submission and reduce preventable delays.
How long does ARTG inclusion usually take for medical devices?
ARTG inclusion timelines vary based on device classification, conformity assessment route, completeness of the submission, and whether TGA requests additional information. Lower-risk devices may move faster, while higher-risk devices often require deeper review and stronger evidence packages. A well-prepared application with aligned technical documentation, labeling, and sponsor details generally improves efficiency and reduces back-and-forth with reviewers.
Can Elexes help if there are issues with ARTG documentation or certificate access?
Yes. Elexes supports manufacturers with TGA documentation alignment, ARTG inclusion support, submission readiness assessments, and responses to regulatory issues that may affect certificate access or market continuity. This includes reviewing classification rationale, conformity evidence, essential principles documentation, and sponsor-linked records so the ARTG entry is accurate, defensible, and easier to manage throughout the product lifecycle.
Still Need ARTG Guidance?
Speak with regulatory specialists about your certificate or TGA requirements.
Certified & Trusted
Awards and Recognition
ISO 13485
Medical device quality systems expertise.
MDSAP
Supports multi-market audit readiness.
IEC 62304
Software lifecycle compliance expertise.
