Regulatory Affars Medical Devices Consulting Blog
Monitoring the changes and keeping up with the medical device legislation, standards, and guidelines set by the Therapeutic Goods Administration and other regulating agencies is challenging for small and medium scale medical device manufacturers. However, to be able to market products and reach target markets, it is important that these manufacturers comply with all the regulations.
Vicki Partridge’s high quality medical device consulting services are designed to help medical device manufacturers through all facits of product design, development, approval, and ongoing after-market activities. Our goal is to provide manufacturers with a clear understanding of the requirements needed throughout the product life cycle and help you with the regulatory affairs medical devices registration.
Preparing for a Pre-Market Assessment by the TGA
Before specific medical devices can be included in the Australian Register of Therapeutic Goods (ARTG), they may need to undergo…
ARTG Inclusion Process Explained for Australian Manufacturers
If you intend to supply a medical device in Australia, you need approval from the Therapeutic Goods Administration (TGA) before…
Clinical Evaluation Reports Mistakes That Risk TGA Delays
Clinical Evaluation Reports (CERs) are critical in showing that a medical device meets safety and performance standards for TGA submissions.…
Implantable Medical Device in Australia and Essential Principles
An implantable medical device in Australia must meet safety and performance requirements to gain market approval. From 25 November 2021,…
Understanding Good Manufacturing Practice for Medical Device
Achieving TGA compliance requires that your medical devices be manufactured under strict and consistent standards. Good manufacturing practice (GMP) plays…
Impact of Non-Compliance with TGA Medical Device Regulations
Compliance with TGA medical device regulations is essential for entering and remaining in the Australian market. These regulations require manufacturers,…
TGA Adverse Event Reporting: Essential Guidelines for Sponsors
The TGA adverse event reporting is a key part of post-market surveillance, ensuring that therapeutic goods, including medical devices, remain…
What Is a QMS Audit Checklist for Medical Devices?
A Quality Management System (QMS) is essential for medical device manufacturers to maintain product quality and comply with regulations. A…
Importance of Design Controls in Medical Device Development
Design control in medical device companies refers to a structured process that guides the development of medical devices to ensure…