TGA Australia Delays in Medical Device Conformity Assessment Recertification regulation MDR
Australia Medical Device Regulations

Agency
All medical devices are regulated by the Australian Therapeutic Goods Administration (TGA). (The Office of Devices Authorization is responsible for pre-market regulation, but the Office of Product Review oversees post-market regulations.)
Medical Device Definition
  1. Any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
    1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
    3. Investigation, replacement or modification of the anatomy or of a physiological process;
    4. Control of conception;
    5. And that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
      1. Any instrument, apparatus, appliance, material or other article specified under subsection (2A); or
      2. Any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or
  2. An accessory to such an instrument, apparatus, appliance, material or other article covered by paragraph (a), (b) or (ab). Therapeutic Good Act 1989
Classification of Medical Device
International ClassificationDescriptionExamplesRisk Level
Class ISimple with history of safe useScalpels, compression bandages, dental kitsLow
Class II a relatively low risk to the human bodyHearing aids, masks for providing anaesthesia,Low - Moderate
Class II bRelatively high risk to the human bodyCondoms, blood bags, infusion pumps,High - Moderate
Class IIIDevices that may endanger the Patient's lifeCardiovascular stents, joint prostheses, heart valvesHigh
Premarket Approval Process *
Class I (non-measuring, non-sterile)Class I(sterile, measuring)Class II aClass II bClass III
Appoint an Australian Sponsor to act as the liaison between TGA and device company. (System places vigilance responsibility on sponsor.)
Prepare Declaration of Conformity and Dossier for submission
Sponsor obtains a copy of the manufacturer's evidence and submits it to the TGA for review. An Australian Declaration of Conformity must be submitted if requested.
Sponsor submits applications. Pay application fee
Level 2 audit will be performed on application
The TGA will review application. TGA may ask for more documents at this point, which the sponsor must submit in 20 working days. If approved by TGA listing will be included in the ARTG database on the TGA website.

* See Appendix 1,2

Appendix 1Appendix 2

Certification of Medical Devices Government Flowchart


Post-Market Surveillance Details

“Clause 7.5(3) of the special procedure for systems and procedure packs requires the manufacturer to establish a post-market surveillance system to:
systematically review experiences gained after the device is supplied in Australia; implement any necessary corrective action in relation to the production of the device; notify the TGA of adverse events and near miss events; notify the TGA as soon as practicable about information relating to malfunction or deterioration of its device; notify the TGA as soon as practicable about any inadequacy in the production, labelling, instructions for use, or advertising materials of its device.” (Australian Regulatory Guidelines for Medical Devices, Section 16. Systems and procedure packs)

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