Asia-Pacific Roundup: CDSCO grants flexibility to ease transition to new device requirements

India’s Central Drugs Standard Control Organization (CDSCO) has set out the revised timelines for the move of some devices to a new regulatory framework. CDSCO had originally planned to transition the devices to the drug regulatory framework in April, but the move was delayed by COVID-19.
 
With manufacturers of the CT scanners, implantable devices, MRI equipment and other products affected by the change calling for more time, CDSCO agreed the disruption caused by COVID-19 had set back preparations and created the risk of supply problems if the transition happened in April. The agency agreed to give manufacturers more time in April. Now, CDSCO has shared details of the next steps.
 
CDSCO will allow manufacturers and importers that are already active to continue operating, provided they submitted a request to the Central License Authority or a State License Authority by 18 April 2021 to continue supplying their devices under the Medical Device Rules (MDR) of 2017. The flexibility will last until the company is licensed under MDR or until 30 June 2022.
 
Manufacturers and importers that submitted applications by 18 April but failed to provide all the requested information can keep their products on the market as well. CDSCO is giving companies in that situation until the end of March to complete their applications. The agency expects state and central licensing authorities to “dispose of these applications within three months from the date of receipt of complete application.”
 
The timeline means all manufacturers and importers of the affected devices will need to include the license number on their product labels from 1 July onward.
 
CDSCO Notice
 
TGA posts warning about inappropriate promotion of COVID-19 treatments
 
Australia’s Therapeutic Goods Administration (TGA) has issued a warning about the inappropriate promotion of products to treat and prevent COVID-19. TGA used the warning to remind advertisers about what it considers to be therapeutic use claims and the rules about making them.
 
The notice lacks details of the specific products that triggered the warning but talks broadly about the types of goods that are a cause for concern, as well as the sorts of claims advertisers are making about them. TGA said it has “identified certain therapeutic goods such as complementary medicines or disinfectants” that are being promoted inappropriately, before adding examples of statements related to face masks, supplements and disinfectants that it sees as therapeutic use claims.
 
“The promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation. We remind advertisers to be very careful when considering making therapeutic claims related to novel coronavirus,” the warning states.
 
In Australia, claims that a face mask or disinfectant prevents the spread of coronavirus, or that a supplement increases immunity to coronavirus, are considered to be therapeutic use claims. That status puts requirements on advertisers. All advertising of therapeutic goods that refers to the novel coronavirus needs prior approval from TGA. Any therapeutic claim related to the virus must be backed by “appropriate evidence.” Clinical data is needed to support claims in humans.
 
TGA dedicated a section of its notice to disinfectants, explaining that advertisements need to comply with the Therapeutic Goods Act and Therapeutic Goods Advertising Code, regardless of whether the product is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG). Products that claim virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity must be included in the ARTG. Claims related to coronavirus likely need evidence specific to the virus.
 
TGA Notice
 
TGA gives industry until August 2022 to register custom-made medical devices
 
TGA has extended the deadline to register custom-made medical devices until 25 August 2022. The delay gives companies more time to access the transition period created by TGA to ease the move to the new regulatory framework.
 
The framework, which commenced in February, will require many personalized medical devices to be registered in the ARTG for the first time. While the framework is now in effect, manufacturers of existing custom-made medical devices can benefit from a transition period that is set to run until 1 November 2024, provided they register in time.
 
TGA originally set the deadline for registration as August 2021. However, the agency has pushed the deadline back by 12 months, giving companies until 25 August 2022 to complete the online form it has created to register custom-made medical devices. TGA is also allowing companies to provide up to five of a kind of patient-matched medical device in a financial year without adding it to the ARTG. 
 
TGA Notice, More
 
TGA updates guidance on software for use with COVID-19 rapid antigen self-tests
 
TGA has updated its guidance on software for use with COVID-19 rapid antigen self-tests. The update clarifies when software is treated as a medical device and adds a sixth example of the application of the rules.
 
Most of the text is unchanged from the version released by TGA in September. TGA has expanded its explanation of when software is regulated as a medical device.
 
The original text said software that analyzes or enables interpretation of the test sample or results in any way is a medical device. The update states, “This also applies to secondary analysis or quality checking of a result that is performed by the software.” TGA also added that software that is only used to view results is not classed as a medical device.
 
Elsewhere, TGA added another example. The scenario describes the use of an app to upload a photograph of the test result to the website of the test provider for viewing by another person. TGA will not regulate such software as a medical device because it “enables transmission of the photograph for viewing and storage purposes only” and, “No analysis is performed by the software to enable a secondary interpretation of results.”
 
TGA Guidance
 
Malaysia’s MDA issues notice about claims related to medical devices
 
Malaysia’s Medical Device Authority (MDA) has reminded advertisers about the need to comply with the Medical Devices Act 2012 and the Medical Devices (Advertisement) Regulations 2019.
 
MDA issued the notice in response to an article in a newspaper about a nasal spray. According to MDA, the article made the misleading claim that the nasal spray can prevent and treat viral infections, including COVID-19. However, the spray is only approved for washing and detoxifying contaminants in the nasal cavity, and not for preventing or treating COVID-19.
 
The agency has asked the holder of the device registration to take appropriate action to correct the statements in the article and inform it of the steps taken. MDA is concerned the claims could confuse the public and lead to the misuse of the nasal spray. The agency used the case to make a broader point about the need to comply with advertising rules and the penalties for failing to do so.
 
MDA Notice (Malaysian)
 
Other News:
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published a directive on the need to register clinical research performed in healthy volunteers in a national database. The database specifically covers the registration of healthy volunteers in Malaysian clinical research. NPRA Notice (Malaysian)