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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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Overview of the role of Key Stakeholders in the Medical Device Regulations

The new MDR will apply across EU Member States from May 2020, under this regulation there are defined obligations which lie with the major stakeholders in the device lifecycle. These obligations need to be fulfilled to ensure compliance with the regulation when placing the device on the market. Manufacturer Dependent on classification of the device, will get a CE certificate from the Notified Body or self-certify the device. Affix CE mark. Responsible for placing CE marked product on the market. Responsible for registering products on the EUDAMED database Retain technical documentation, CE......

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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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Unique device identifiers (UDI)

What is it? This is a system by which medical devices are identified through their distribution and use. UDI information must be placed on the label and/or package of the device and will be both human and machine-readable form. The UDI is a set of alphanumeric codes which consists of both a device identifier (this is company and product code) and production information (manufacturing information: product name, expiration date, lot/batch numbers, manufacturer details). How and when to comply: US (FDA)In 2013 the FDA released a rule which determined that there would be......

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Understanding MDSAP

MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulatory agencies: • Therapeutics goods Administration (TGA) – Australia • Agência Nacional de Vigilância Sanitária (Anvisa) – Brazil • Health Canada (HC) – Canada • Food and Drug Administration (FDA) – US • Ministry of Health and Labour and Welfare (MHLW) – Japan The benefit of MDSAP, is one single quality system inspection that will encompass 5 markets versus having to complete 5 separate audits. One single audit......

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The Importance of Risk Management

Risk management is a key component to demonstrate regulatory compliance for medical devices, it contributes to the medical device company’s ability to meet the regulatory requirements for approval from local regulatory authorities. Effective risk management is essential for determining whether the benefits of the product outweigh any potential risk to the patient. ISO 14971 ’Medical devices – Application of risk management to medical devices’ is the international standard for the application of risk management by a manufacturer to medical devices, including in vitro diagnostics (IVD’s). ISO 14971 is accepted by the TGA......

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Why is it so important to review and update your regulatory strategy?

Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of the new MDD and further changes planned for the coming years, it is important that a regulatory strategy is reviewed and updated as new and updated requirements are identified. New requirements and/or updates could have a significant impact on existing or new products. Regulatory standards are used to assess the safety, efficacy and quality of medical devices throughout the product lifecycle. There’s......

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Why is regulatory strategy so important?

The global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies. With many changes planned for the next few years, a regulatory strategy ensures that you are well informed and aware of all existing requirements as well as any new or updated ones, which may impact the marketing of your device. We define the regulatory strategy as the ‘roadmap to market’ – because this describes the regulatory requirements that need to be addressed. There are a......

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