Engel Hellyer & Partners is one of the most trusted and experienced Pharmaceutical TGA and AICIS Regulatory Affairs consultants.
Since 1982, we have been providing quality regulatory advice to large multinationals and SMEs.
Australia has a well-established Medical Device and In Vitro Diagnostic Medical Device (IVD) compliance framework regulated by the Therapeutic Goods Administration. We are established and trusted TGA Medical Device Consultants and will work with you to ensure a successful medical device application!
Medical devices include such products, such as surgical masks, sterile water, medical electronic thermometers, medical gloves, needles, wound dressings and monitors to measure functions of the body and many other products.
We can help you decide if your product is a medical device or not and if it has to be included in the TGA’s Australian Register of Therapeutic Goods. The definition of a medical device is a device intended by the manufacturer to be used on humans for any of the following:
- diagnosis, prevention, monitoring, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
- investigation, replacement or modification of the anatomy or of a physiological process
- control of conception
or is used as an accessory to any product as described above
Products that are not medical devices may be another therapeutic good such as a medicine or a disinfectant. Alternatively some products may a cosmetic.
We will also assist you in becoming a sponsor with TGA and sourcing the documents needed to make applications on line to have your medical device or invitro device included on the ARTG.
The Process & Documentation Requirements
All manufacturers of medical devices and IVDs need to be advised to and approved by the TGA at the beginning of the application process. All medical devices must comply with a set of quality standards known as the Essential Principles. Documentation acknowledging adherence to these principles by the manufacturer is required and this may be in the form of a Declaration of Conformity using the TGA format for most Class 1 medical devices or a CE Certificate for Class 2, 3 or 4 medical devices and Class 1 Measuring or Class 1 Sterile Products. Declarations of Conformity are to be provided and signed by the manufacturer. We can help to write these. Alternatively CE certificates are awarded to a manufacturer by an inspecting organization called a notified body after a very detailed medical device inspection. There are over 50 approved notified bodies acceptable to the TGA.
Once the manufacturer is approved the online process will allow details of the device and the sponsor to be entered and linked. Each medical device will have a generic name and number used to identify the type of medical device product. This is called its Global Medical Device Nomenclature (GMDN).
The online process on the lodgement of an application will generate an invoice and in the case of some higher class medical devices a request for various forms of technical dossiers. TGA will review the applications once the fees and any other documents required provided. An approval will result in TGA issuing a letter advising success and an ARTG Inclusion number.
Medical devices that have been approved and are being supplied in the European Union have an advantage in being approved for supply in Australia due to the similarities of treatment of these products by the two jurisdictions
The key legislation setting out the legal requirements for the import, export, manufacture and supply of medical devices and IVDs are:
- Therapeutic Goods Act 1989
- Therapeutic Goods Regulations 1990
- Therapeutic Goods (Medical Devices) Regulations 2002