Posted in CEO Updates

Refinements to the regulation of personalised medical devices

Posted by ADIA on 24 August 2021
Refinements to the regulation of personalised medical devices

As you are aware the ADIA has worked closely with the Therapeutic Goods Administration (TGA) over the past 18 months on the development of the personalised medical devices framework.

On Monday the TGA announced a number of options for refining the framework that were identified as a result of the public consultations held over the last few months.

The ADIA advocated for a number of options to be considered in the development of the framework which included:

  1. A review of Class 1 and Class IIa devices with a view to excluding very low risk products from Australian Register of Therapeutic Goods (ARTG) inclusion.
  2. Continuing to include raw materials and components that are used to make medical  devices in the ARTG.
  3. Maintaining a level playing field for all manufacturers of medical devices.
  4. The ADIA suggested implementing a templated process to achieve a QMS system to reduce costs for the small laboratories and manufactures which was highlighted in a Risk Statement submitted by the ADIA in the initial consultation process.

In today's announcement the TGA have advised that: 

  1. A limited number of low risk devices would be excluded from being considered to be medical devices.
  2. Raw materials and components would stay on the ARTG.
  3. The person assembling the low risk device would not need to include the device in the ARTG. 
  4. The person assembling the device, including if they are a healthcare practitioner, will still need to meet all other regulatory requirements for medical devices.

An overview of these legislative instruments and their impact can be found on the TGA website.

What is required now?

If you manufacture or supply a product that has been included in the excluded goods determination, you do not need to register for transition or include the device in the ARTG.

If you have already registered a product that has been included in the excluded goods determination you are not required to take any further action.

Please Note:

If companies reacted to the TGA email re removing items from the ARTG before June 30 by deleting those entries, the ADIA will work with the TGA on the process for reinstating those entries.

Please reach out to the ADIA with a summary of how many ARTG entries were cancelled, and also advise on any applications rejected on the basis of the TGA position on raw materials, that will now need to be resubmitted

Posted in:TGAIndustry NewsCEO Updates  

COVID-19 restrictions increased in NSW

Posted by ADIA on 23 August 2021
COVID-19 restrictions increased in NSW

The NSW Government has extended the current lockdown in Greater Sydney until the end of September and introduced new rules targeting the 12 local government areas (LGAs) of concern.

Areas of concern include: Bayside, Blacktown, Burwood, Campbelltown, Canterbury-Bankstown, Cumberland, Fairfield, Georges River, Liverpool, Parramatta, Penrith and Strathfield.

Additional rules for the LGAs of concern from today, Monday, 23 August, 2021.

Curfews will be introduced from 9:00 PM to 5:00 AM (except for authorised workers, emergencies, or medical care).

New restrictions around workplaces and authorised workers from the LGAs of concern will be introduced:

  • Authorised workers who work outside their LGA of concern are only permitted to work if rapid antigen testing is implemented at their work-site or they have had their first vaccination dose by 30 August.
  • From Saturday, 28 August, authorised workers from the LGAs of concern are required to carry a permit from Service NSW declaring that they are an authorised worker and cannot work from home.
  • From Saturday, 28 August, anyone entering an LGA of concern for the purposes of work must carry a worker permit issued by Service NSW.

Additional measure for Greater Sydney and regional NSW

From Monday, 23 August, mask wearing will be mandatory when outside your home, except when exercising for Greater Sydney (including regional NSW until 28 August).

Further information about the new measures can be found on the Business Australia website.


Posted in:Industry NewsCEO UpdatesCovid News  

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