The US Food and Drug Administration (FDA) is the agency tasked with reviewing new devices and making amendments to already approved devices. More specifically, medical device approval is done through the FDA's Center for Devices and Radiological Health (CDRH).
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health , and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
Medical devices help doctors and health professionals to diagnose, prevent, treat and monitor medical conditions. They include things like surgical equipment, syringes, gloves, pacemakers, baby incubators and implants. Find out what we're doing to make sure these products are safe to use.
The TGA may agree upfront to accept a limited number of rolling submissions of data during the evaluation phases, as well as reports from comparable overseas regulators. The TGA will make a preliminary assessment whether to accept the submission for evaluation and will notify the sponsor.
Australia -US Food Safety Recognition ArrangementThe department signed an agreement with the US Food and Drug Administration (US FDA) in April 2017, recognising Australia's food safety system and the US food safety system are comparable/ equivalent to each other.
TGA will protect information received from FDA to the extent allowed under Australian law. TGA intends to use information it receives from the FDA only to assess the compliance of human pharmaceutical facilities or products manufactured, distributed, or offered for distribution within the Commonwealth of Australia.
Here are the 6 steps involved
- Check if your product is a therapeutic good.
- Decide whether you want to have it approved in your name to supply it in Australia.
- Find out what type of therapeutic good the product is and review the relevant guidelines.
- Understand the legal requirements for your product to be approved.
PMA and PMN (aka 510[k]) applications for medical devices are reviewed by the CDRH within the FDA. Within that center are the Office of Device Evaluation and the Office of In Vitro Diagnostics and Radiological Human Health. Within these offices, the divisions are organized according to device specialties.
Your intended use and indications of use statements are integral to getting your medical device to market. These statements help insure your device meets regulation when used properly. Second, your indication of use statement are the precise situations and reasons where and why you would use this device.
If you have already acquired the European CE Marking, the TGA approval process will be easier since the Australia recognizes CE Marking. A CE Marking certificate from a Notified Body is generally accepted by the Therapeutic Goods Administration (TGA) as part of your registration.
The processing time for the entire application may take from 3 to 8 weeks, or longer, depending on the completeness of the application. If an Application Audit is required, the time-frame will be 3 – 6 months.
Hospitals and other medical facilities can purchase supplies through a group purchasing organization or negotiate directly with distributors or wholesalers, all of whom are doing a larger share of their business online.
Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment. They generally have a physical or mechanical effect on the body, or are used to measure (or monitor) the body and its functions.
“ISO 13485 Certified†means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.
The TGA is required to complete conformity assessment applications
within 255 working days.
5. Medical Devices.
| 2015 Jul-Dec | 2016 Jul-Dec |
|---|
| New devices |
|---|
| Mean TGA processing time (working days) | 137 | 118 |
| Median TGA processing time (working days) | 178 | 133 |
| Changes or recertification |
The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods such as medicines, medical devices, and diagnostic tests.
The Council of Financial Regulators (CFR) is the coordinating body for Australia's main financial regulatory agencies. There are four members – the Australian Prudential Regulation Authority (APRA), the Australian Securities and Investments Commission (ASIC), the Reserve Bank of Australia (RBA) and The Treasury.
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics.
The licensing/certification process. Australian medicines manufacturers are required to obtain a licence to manufacture therapeutic goods (sometimes referred to as GMP licence). Overseas medicines manufacturers, where GMP clearance is based on a TGA inspection, obtain GMP Certification when passing a TGA inspection.
What is the Australian Register of Therapeutic Goods or the ARTG? The ARTG is a database of therapeutic products overseen by the Australian government. It holds a record of medicinal goods and devices for human use approved for supply in or to be exported from Australia.
Certificates of free sale and export certificates are documents supplied by the Therapeutic Goods Administration (TGA) outlining that the relevant medical device(s) are included in the Australian Register of Therapeutic Goods (ARTG) and are either able to be freely supplied and sold within Australia or are able to be
CE marked products can be sold in all 15 member states of the European Union plus Norway, Iceland and Liechtenstein, which collectively make up the European Economic Area (EEA). It provides for certain Australian and New Zealand products to be assessed in Australia / New Zealand against European requirements.
Japan does not accept CE marking and/or an FDA certificate although European and US approval does help to expedite the review process.
The MDSAP will become mandatory for all manufacturers who wish to sell their medical device products to other global markets. Later, the United States, Brazil, Australia and Japan will follow the MDSAP program.
CE marking on products is mandatory in all EU member countries, as well as in Norway, Iceland and Liechtenstein that are part of the EEA. Moreover, the certification procedure also is required in Switzerland because of the transposition of the Medical Device Directives into their national law.
Applying for a licence or GMP certification
- Making a statutory declaration.
- Drafting and submitting your application. Submitting a TGA manufacturing licence application. Submitting a GMP certification application.
- Paying the application fee.
- Determining your application's effectiveness.
The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.
