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Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

Posted 12 October 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

TGA releases guide to classifying active medical devices by risk
 
New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.
 
The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU where possible, uses the same term and some of the same language as the MDR; the Australian regulator has followed the EU’s lead by releasing guidance designed to help developers of active medical devices classify their products based on the level of harm they may pose to users or patients.
 
In the guidance, TGA describes the classification rules that may apply to active medical devices. More than one rule will apply to many products, particularly if they are “complex and multi-functional medical devices.” TGA wants developers to consider each function of the medical device and use the highest possible classification for the product as a whole when including it in the Australian Register of Therapeutic Goods.
 
Some of the rules are specific to active medical devices for diagnosis or therapy. Rule 4.3 applies to active devices used to “supply information for the purpose of detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities,” for example by delivering energy that is absorbed by the patient or imaging the distribution of radiopharmaceuticals in the body. Depending on the specific function, such devices fall into Class IIa or Class IIb.
 
The rule that is specific to active medical devices for therapy, 4.2, applies to products that are “used to administer energy to a patient, or exchange energy to or from a patient.” The sub-rule that applies depends on whether the product is used to administer or exchange energy in a non-hazardous or potentially hazardous way. Hearing aids are deemed non-hazardous, putting them in Class IIa, while lung ventilators are in Class IIb as the energy transfer is potentially hazardous. Active medical devices for therapy that significantly determine patient management will soon be moved to Class III.
 
TGA is moving the devices to Class III as part of a broader reclassification slated to occur on 25 November. The move will also affect active implantable medical devices. Currently, active implantable medical devices have their own risk classification, AIMD, but that will change next month when they join Class III. TGA cites pacemakers as an example of active implantable medical devices.
 
TGA Guidance
 
New Zealand’s Medsafe misses multiple timeline targets in 2021
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) missed multiple targets for completion of the initial evaluation of higher-risk medicines over the first half of the year.
 
Medsafe aims to complete the initial evaluation of higher-risk medicines in 200 calendar days. Over the first half of 2021, the regulatory agency took between 51 and 322 calendar days. The mean and median evaluation times were 237 and 277 calendar days, respectively, far exceeding the target and the sub-200-day turnaround time achieved by Medsafe last year.
 
The higher-risk initial evaluation target is one of several goals missed by Medsafe over the first half of the year. Medsafe took almost twice as long, on average, as targeted to finish the initial evaluation of abbreviated higher-risk applications, with the mean and median coming in just either side of 200 calendar days compared to the target of 100 calendar days. Medsafe took at least 159 calendar days to complete the initial evaluations of abbreviated higher-risk applications.
 
Medsafe also missed its targets for the initial evaluation of normal and abbreviated intermediate-risk products, but hit its priority review objective. The relatively small numbers of filings handled by the regulator over the first half of 2021, when it received seven higher-risk filings and the same number of priority review submissions, mean the averages can be skewed by outliers.
 
The trend between 2020 and the first half of 2021 is consistent, though. Mean time to completion of the initial evaluation increased for six of the seven filing types tracked by Medsafe over the first half of the year, although some of the times were still below their targets even after rising.
 
Medsafe Report
 
TGA advises on discussing COVID-19 testing in therapeutic goods adverts
 
TGA has published advice on how to lawfully include statements about COVID-19 testing in advertisements for therapeutic goods in Australia. The guidance features language advertisers can include to comply with regulations on the promotion of therapeutic goods.
 
As TGA explains, the use of COVID-19 testing advice statements is optional. However, since TGA allows the sponsors of some therapeutic goods to “expressly refer to COVID-19 in the context of advising individuals to follow health advice about COVID-19 testing” to support the government’s health messaging, the agency has set out compliance parameters for referring to COVID-19 testing in ads.
 
TGA has proposed two statements advertisers can use, both of which are variations on “if you have symptoms relating to COVID-19, seek health advice about getting tested.” Sponsors can also use general statements such as “get tested,” “stay at home if you are unwell” or “follow health advice” in advertising. The overall ad must still be consistent with public health messaging.
 
The arrangements are set to stay in force until the end of next year.
 
TGA Notice
 
Philippine FDA posts guidelines on licensing of medical device retailers
 
The Philippine Food and Drug Administration (FDA) has posted guidelines on the licensing of retailers of medical devices. FDA published the guidelines as part of a push to counter the “proliferation of unregistered medical devices.”
 
Under the requirements set out in the guidelines, medical device retailers need to apply for a license to operate (LTO) and “conspicuously” display the document inside their establishments. Retailers must comply with the same qualified person qualification and credential requirements as companies that manufacture, trade and distribute medical devices.
 
FDA set out the need for the regulations, explaining that in the absence of the LTO requirement “these establishments or entities are not compelled to comply with the government regulations covering the said health products which cause the proliferation of unregistered medical devices in the market as evidenced by the numerous issued FDA Advisories.”
 
The guidelines also describe the post-licensing inspections FDA will use to ensure compliance.
 
FDA Guidelines
 
TGA answers questions about Global Medical Device Nomenclature terms
 
TGA has answered frequently asked questions about Global Medical Device Nomenclature (GMDN) terms to help sponsors and manufacturers use the international naming and grouping convention.
 
The document explains the benefits of GMDN terms, where to find them and how to pick the right term for a medical device, before answering nine more specific questions about the nomenclature. Companies that cannot find a suitable term should contact the GMDN agency and discuss how to handle situations in which a term is missing from TGA Business Services.
 
TGA has also provided a case study about choosing the right GMDN term. The case study describes a search for the appropriate term for dentures and overdentures for the upper and lower jaw that are made using four different materials. TGA concludes that four GMDN terms, based on how the device is used rather than what it is made of, are applicable to the products.  
 
TGA FAQ

 

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