Tag: TGA medical device consultant


Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices

What is a valid ISO 13485 QMS certificate accepted by the TGA? International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The TGA accepts ISO 13485 certificates issued by Notified Bodies or an International Accreditation Forum (IAF) certified conformity assessment body. Refer to the Table provided below for a summary of TGA accepted manufacturer’s evidence for IVD medical devices.   What is changing? The COVID-19 pandemic had a significant impact on the IVD industry which was burdened with......

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Personal Protective Equipment (PPE) Regulation as a Medical Device by the TGA

Due to the COVID-19 pandemic, the demand for PPE has significantly increased. In response to the greater demand, the TGA has issued guidance on the regulation of face masks, gloves and gowns. The regulation is dependent on the product type and its therapeutic purpose. What is PPE? PPE refers to clothing and equipment (face masks, gloves and gowns) used to protect an individual against one or more health and safety hazards. When is PPE considered a medical device? The regulation defines PPE as articles that are non-sterile personal protective equipment or safety......

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TGA Medical Device Class I Update – Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices

What does this mean? The TGA has changed the inclusion process by which non-measuring, non-sterile Class I medical devices are included in the ARTG. The changes came into effect October 2020. What has changed? The TGA has modified the process, by which Class I inclusion applications in the ARTG are done. The application has been updated with additional requirements; applicants must now provide a manufacturer’s Declaration of Conformity when applying to include the device on the ARTG. The Manufacturer’s Declaration of Conformity form for these devices has been amended, making it more......

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TGA’s Medical Device Regulatory Changing Landscape

In 2020, the TGA are implementing a range of changes to the medical device regulations due to a number of reasons; some of which include changes to the European device regulations and new technologies now considered medical devices. The TGA have released an Action Plan, which has a 3-strategy approach to implementing the changes. The Action Plan Strategy 1 – Improving how new devices get on the market The TGA is strengthening its assessment processes and oversight of how devices are approved for use on the Australian market. Better assessment of new......

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Considerations when outsourcing manufacture of medical devices

In the modern era of manufacturing its common for a company to make the decision to outsource part or full manufacturing of medical devices to a sub-contract manufacturer/critical supplier. There are many reasons for the medical device manufacturer to do this i.e. expertise, scale of manufacture, latest technology and cost. Its vitally important to select the right sub-contract/critical supplier manufacturer. How to find the right sub-contract/critical supplier manufacturer: Size – This will determine their ability to meet your manufacturing needs, whether this is with specialised equipment or the newest technologies. Consider the......

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Importance of Data Integrity and Document Management

In recent years there has been increased emphasis on data integrity, as this is a critical factor for the manufacturer in measuring the quality of their product and their credibility. What is Data integrity? Every organisation knows the saying, ‘If it isn’t written down, it didn’t happen’, this is fundamental in a manufacturing environment. Data is essential in the manufacturing process, without data how can the integrity of the product or processes be proven, without data it is harder to identify risks and opportunities for improvement. The FDA identify data integrity as......

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Importance of Post Market Surveillance for medical Devices

Post market surveillance (PMS) activities are part of the manufacturer’s overall quality management system, whereby it provides continuous feedback about a device on the market, ensuring that a high standard of product quality is maintained, as it monitors the safety of the device post launch. PMS is a requirement for the main markets i.e. US, Europe, Australia, etc. In Australia, the Therapeutic Goods Administration (TGA) is responsible for medical devices, this includes the monitoring of the ongoing safety, performance and quality, of devices which have been included on the Australian Register of......

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Road to registering your medical device in Australia

In Australia the Therapeutic Goods Administration (TGA) overseas the medical devices which are placed on the market. The TGA enforces the Therapeutic Goods (Medical Devices) Regulations 2002 as amended. Guidelines to the Regulations can be found at Australian Regulatory Guidelines for Medical Devices (ARGMD). Pre-market: Determine if your product is a medical device? Does your product meet the definition of a medical device, whereby the product is intended to be used on humans for any of the following; Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or......

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Post Brexit Market Access for Medical Devices

With a Brexit deal or no Brexit deal still on the cards, when either outcome comes into effect, the UK will be considered a third country. Countries which are located outside the EU are considered ‘third countries’. To ensure uninterrupted market access, it is advised for manufacturers to prepare for Brexit. Implications for product on the Australian market: The TGA will continue to recognise conformity assessments from UK based Notified Bodies for existing and new ARTG listings and applications. The TGA will recognise: Device certifications by UK notified bodies through 31 Dec......

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The Advertising Code 2018 vs. ISO 15223-1

Do you need to comply with the Advertising Code 2018 if you already comply with ISO 15223-1? The answer is yes! Selling medical devices on global markets requires that labelling must comply with local region labelling and advertising requirements. Each country will have specific requirements, so how are they addressed to satisfy Australian Market requirements? First thing to consider for your device, does the labelling requirements meet the Essential Principle 13.1, schedule 1, Part 2. This information can be depicted with the use of symbols defined in ISO15223-1 Medical Devices – Symbols......

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