Regulatory News & Insights

26 September 2026

One-Day Training: Custom-Made Devices in Australia and Europe

A one-day CMS SciDoc training session on the regulatory requirements for custom-made medical devices under the TGA in Australia and EU MDR 2017/745.

26 September 2026

Change Management and CAPA Process Training from CMS SciDoc

CMS SciDoc runs practical Change Management and CAPA Process Training, from initiating a CAPA and root cause investigation to effectiveness checks.

5 September 2026

EU Authorised Representative Services for Medical Devices and IVDs

MDR or IVDR compliance is only the first step. To place a device on the EU market you must appoint a qualified EU based Authorised Representative.

5 September 2026

Medical Device Registration in India: CDSCO and In-Country Representation

India's medical device market is projected to exceed USD 50 billion by 2030. CDSCO regulatory strategy, device registration and in-country representation.

5 September 2026

Medical Device Registration in South Korea

End to end support for medical device registration in South Korea, including MFDS liaison and acting as your local Authorised Representative.

5 September 2026

Clinical Evaluation Reports under EU MDR

End to end CER authorship under EU MDR: literature review, equivalence assessment, critical appraisal, and integration of PMS, PMCF and risk management data.

5 September 2026

Are You Meeting Your Post-Market Responsibilities as a TGA Sponsor?

Compliance does not stop at market entry. Adverse event reporting, complaint handling, CAPA, post-market surveillance and annual reporting obligations for TGA sponsors.

5 September 2026

Lead Auditor Training Workshop

A four day Lead Auditor Training Workshop aligned with ISO 19011 and ISO 17021, developed for professionals who want to lead audits with confidence and authority.

5 September 2026

Technical Documentation for TGA and EU MDR

End to end technical file preparation for TGA and EU MDR, plus a one day practical training session for regulatory, QA and product teams who want to maintain it in-house.

5 September 2026

ISO 14971 Risk Management and Risk Assessment Training

Risk management across the device lifecycle to ISO 14971, FDA, MDR and TGA requirements, plus a hands-on 2.5 day risk assessment training programme for your team.

5 September 2026

Australian Sponsor and New Zealand Agent Services

Local representation for medical device manufacturers entering Australia and New Zealand: Australian Sponsor, ARTG inclusion, Medsafe liaison and ongoing compliance.

5 September 2026

Independent Internal Audits to ISO 19011

Independent internal audits that identify underlying gaps and prepare you for certification, MDR, IVDR and MDSAP requirements, with clear and actionable reporting.

5 September 2026

ISO 13485 Quality Management System Implementation

Practical, compliant and audit ready quality management systems for medical device manufacturers, from quality manual through to internal audit preparation.

5 September 2026

TGA Clinical Decision Support System Exemptions: What Actually Qualifies

Some Clinical Decision Support Systems are exempt medical devices under TGA regulations, but only if they meet all three criteria. AI enabled CDSS will not meet them.

5 September 2026

Local Authorised Representative Services in Thailand and Vietnam

Entering Thailand and Vietnam goes beyond regulatory approval. Registration with the Thai FDA and Vietnam MOH, vigilance, post-market surveillance and legal representation.

5 September 2026

Is Your Biocompatibility Documentation Regulatory Ready?

Biocompatibility is more than completing a list of biological tests. Your biological evaluation should be device specific, scientifically justified and risk based.

5 September 2026

Regulatory Strategy Services for Medical Devices

A clear regulatory strategy streamlines market access, reduces regulatory risk and avoids costly delays. What a regulatory strategy covers and when to develop one.

5 September 2026

Compliance Management Solutions and SciDoc Solutions Join Forces to Create CMS SciDoc

Compliance Management Solutions and SciDoc Solutions have combined their regulatory consultancy practices to create CMS SciDoc, a team of 25 specialists supporting medical device and IVD manufacturers worldwide.

15 July 2026

ISO 13485 for Medical Device Market Readiness

A medical device can be clinically promising, commercially viable and technically sophisticated, yet still face delays if its quality system cannot demonstrate…

14 July 2026

How to Prepare TGA Technical Documentation

A technical file assembled just before an ARTG application often exposes issues that began much earlier: an intended purpose that does not match the clinical…

13 July 2026

MDSAP: What Medical Device Manufacturers Need to Know

A single quality management system audit can influence market access across Australia, the United States, Canada, Brazil and Japan.

12 July 2026

How Long Does ARTG Inclusion Take in Australia?

A product launch can look ready from a commercial perspective and still be held up by one regulatory question: how long does ARTG inclusion take?

11 July 2026

EU MDR 2017/745 Requirements for Manufacturers

A CE mark is no longer simply a market access milestone achieved at the end of development. Under EU MDR 2017/745, it is the visible outcome of an ongoing…

10 July 2026

Medical Device Market Access Guide

A strong product can still stall at launch if market access was treated as a late-stage regulatory task.

9 July 2026

How to Prepare FDA 510k Submission

An FDA reviewer rarely rejects a 510(k) because a sponsor missed one headline requirement. More often, delays happen because the submission tells an incomplete…

8 July 2026

TGA Sponsor vs Importer: What’s the Difference?

If a medical device is heading into Australia, one of the first questions to settle is TGA sponsor vs importer – because the answer affects who carries legal…

7 July 2026

How to Plan Regulatory Submissions Well

A submission rarely goes off track because of one major issue. More often, it slips because classification was assumed too early, evidence gaps were found too…

6 July 2026

What Does a TGA Sponsor Do?

Bringing a medical device into Australia is not simply a matter of shipping product and starting sales.

4 July 2026

When Do ARTG Changes Need Reporting?

A product is already included in the ARTG, supply is underway, and then the change requests start landing – a new label, a manufacturing update, a revised…

2 July 2026

How to Implement ISO 13485 Properly

If your team is treating ISO 13485 as a document-writing exercise, you are already behind. The companies that implement it well use it to control risk, clarify…

30 June 2026

How to Enter Australian Medtech Market

A strong product and a large addressable market are not enough to guarantee success in Australia.

28 June 2026

How to Classify Medical Devices Correctly

A device classification issue rarely shows up as a simple paperwork problem. More often, it appears later as a delayed submission, unexpected evidence gaps,…

26 June 2026

How to Appoint TGA Sponsor the Right Way

If you are planning to supply a medical device in Australia, working out how to appoint TGA sponsor is not an administrative afterthought.

24 June 2026

Software as Medical Device Regulations

A software release can change clinical functionality overnight. Regulation does not move that quickly, and that gap is where many SaMD projects run into…

22 June 2026

Guide to Australian Device Registration

Bringing a medical device into Australia can stall for reasons that have nothing to do with product quality.

20 June 2026

ARTG Inclusion Requirements Checklist

A product can be technically ready for launch and still miss its market window because the ARTG application was built on incomplete evidence.

18 June 2026

ISO 13485 Implementation Guide for Medtech

A practical iso 13485 implementation guide for medical device firms, covering planning, QMS design, evidence, audits and market readiness.

17 June 2026

Medical Device Classification Australia Explained

Medical device classification Australia explained – how TGA classes work, what affects risk level, and where manufacturers often get it wrong.

16 June 2026

ARTG Inclusion for Medical Devices Explained

ARTG inclusion for medical devices explained clearly – what sponsors need, common delays, and how to prepare for a smoother TGA pathway.

15 June 2026

Who Needs a TGA Sponsor in Australia?

Who needs a TGA sponsor in Australia? Learn which medical device businesses require one, when it applies, and what a sponsor is responsible for.

14 June 2026

TGA Medical Device Sponsor Australia Guide

What a TGA medical device sponsor does in Australia, the risks of a poor sponsor structure, and what to assess before appointing one.

13 June 2026

What a Management Compliance Policy Should Do

A management compliance policy sets accountability, controls and oversight for regulated businesses to reduce risk and support market access.

12 June 2026

Compliance Management System Example

A compliance management system example for medical device firms, with practical structure, ownership, records, audits and post-market control.

11 June 2026

How compliance management companies add value

Learn how compliance management companies help medical device and life sciences businesses reduce risk, meet regulations and reach market faster.

10 June 2026

Global Compliance Management Services Explained

Global compliance management services help medical device firms reduce risk, speed approvals and stay audit-ready across Australia and key markets.

9 June 2026

What a Medical Device Regulatory Affairs Specialist Does

A medical device regulatory affairs specialist helps manufacturers reduce risk, meet TGA and global requirements, and reach market faster.

8 June 2026

How to Get Into Medical Device Regulatory Affairs

A surprising number of people enter medical device regulatory affairs by accident. A quality associate is asked to help with a TGA submission.

7 June 2026

Choosing Medical Device Regulatory Affairs Courses

A delayed submission rarely comes down to one big mistake. More often, it is a series of smaller gaps – device classification misunderstood, essential…

6 June 2026

Medical Device Regulatory Affairs Certification

If you are hiring for a regulatory role, preparing to scale into Australia, or building an internal compliance function, medical device regulatory affairs…

5 June 2026

What Is Medical Device Regulatory Affairs?

A device can be technically brilliant, clinically useful and commercially promising – and still fail to reach market on time if the regulatory pathway is…

1 April 2024

TGA ARTG Medical Device Sponsorship

Under the Australian TGA medical device regulations, a sponsor must apply to include a device in the ARTG before it can be supplied for sale in Australia.