Asia Pacific Summary: CDSCO Provides Flexibility to Ease the Transition to New Device Requirements


India’s Central Pharmaceutical Standards Supervisory Organization (CDSCO) has set revised timelines for certain devices to transition to a new regulatory framework. CDSCO originally planned to move the devices to the drug regulatory framework in April, but that decision was delayed by COVID-19.

Manufacturers of CT scanners, implantable devices, MRI equipment and other products affected by change calling for more time, CDSCO agreed disruption caused by COVID-19 delayed preparations and created risk supply problems if the transition occurs in April. . The agency agreed to give manufacturers more time in April. Now CDSCO has shared the details of the next steps.

CDSCO will allow already active manufacturers and importers to continue their operations, provided they have submitted an application to the Central Licensing Authority or a national licensing authority by April 18, 2021 to continue supplying their devices. under the Medical Device Regulations (MDR) of 2017. The flexibility will last until the company is approved under the MDR or until June 30, 2022.

Manufacturers and importers who submitted applications before April 18 but did not provide all the requested information can also keep their products in the market. CDSCO gives companies in this situation until the end of March to complete their applications. The agency expects national and central licensing authorities “to process such applications within three months from the date of receipt of the full application.”

The schedule means that all manufacturers and importers of affected devices will have to include the license number on their product labels from July 1.

CDSCO Notice

TGA issues warning regarding inappropriate promotion of COVID-19 treatments

Australia’s Therapeutic Goods Administration (TGA) has issued a warning regarding the inappropriate promotion of products to treat and prevent COVID-19. The TGA used the disclaimer to remind advertisers what it considers to be therapeutic use claims and the guidelines for making them.

The advisory lacks details on the specific products that triggered the warning, but speaks broadly about the types of products that are of concern, as well as the types of claims advertisers make about them. TGA said it had “identified certain therapeutic products such as complementary drugs or disinfectants” that are inappropriately promoted, before adding examples of statements relating to face masks, supplements and disinfectants that it considers to be claims. therapeutic use.

“The promotion of therapeutic products to consumers for the prevention or treatment of the novel coronavirus is likely to violate legislative requirements for a variety of reasons, including unsupported claims or limited representation. We remind advertisers to be very careful when considering making therapeutic claims related to the novel coronavirus, ”the warning reads.

In Australia, claims that a face mask or disinfectant prevents the spread of the coronavirus, or that a supplement increases immunity against the coronavirus, are considered claims for therapeutic use. This status imposes requirements on advertisers. Any advertising of therapeutic products referring to the novel coronavirus requires the prior approval of TGA. Any therapeutic claim related to the virus must be supported by “appropriate evidence”. Clinical data is needed to support claims in humans.

The TGA devoted a section of its advisory to disinfectants, explaining that advertisements must comply with the Therapeutic Goods Act and the Therapeutic Goods Advertising Code, whether or not the product is exempt from listing on the Australian Therapeutic Goods Registry (ARTG ). Products which claim virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity should be included in the ARTG. Coronavirus claims likely require virus-specific evidence.

TGA Notice

TGA gives industry until August 2022 to register custom medical devices

TGA has extended the registration deadline for custom-made medical devices until August 25, 2022. This delay gives companies more time to access the transition period created by TGA to ease the transition to the new regulatory framework.

The framework, which began 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 runs until November 1, 2024, provided they register on time.

The TGA originally set the registration deadline for August 2021. However, the agency extended the deadline by 12 months, giving businesses until August 25, 2022 to complete the online form it created for register custom medical devices. The TGA also allows companies to deliver up to five patient-friendly medical devices during an exercise without adding it to the ARTG.

TGA Notice, Following

TGA Updates Software Guidelines For Use With COVID-19 Rapid Antigen Self-Tests

TGA has updated its guidelines on software for use with the COVID-19 rapid antigen self-tests. The update clarifies when software is treated as a medical device and adds a sixth rule enforcement example.

Most of the text is unchanged from the version published by TGA in September. TGA has broadened its explanation of when software is regulated as a medical device.

The original text says that software which analyzes or allows interpretation of the test sample or results in any way is a medical device. The update reads: “This also applies to secondary analysis or quality control of a result performed by the software.” TGA also added that software that is only used to display results is not classified as a medical device.

Elsewhere, TGA added another example. The scenario describes using an application to upload a photograph of the test result to the test provider’s website for another person to view. The TGA will not regulate such software as a medical device because it “allows the transmission of the photograph for viewing and storage purposes only” and “no analysis is performed by the software to allow secondary interpretation of the results. “.

TGA Guide

Malaysia’s MDA issues notice on medical device complaints

Malaysia’s Medical Device Authority (MDA) reminded advertisers of the need to comply with the Medical Device Act 2012 and the Medical Device (Advertising) Regulation 2019.

MDA released the advisory in response to a newspaper article about a nasal spray. According to MDA, the article misleadingly claimed that the nasal spray can prevent and treat viral infections, including COVID-19. However, the spray is only approved to wash away and detoxify contaminants in the nasal cavity, and not to prevent or treat COVID-19.

The agency has asked the registrant of the device to take appropriate action to correct the item’s claims and to inform them of the action taken. MDA is concerned that the claims could confuse the public and lead to the misuse of the nasal spray. The agency used the case to take a broader view on the need to comply with advertising rules and the penalties for non-compliance.

MDA Notice (Malaysian)

Other news:

The Malaysian National Drug Regulatory Agency (NPRA) has issued a guideline on the need to register clinical research performed on healthy volunteers in a national database. The database specifically covers the registration of healthy volunteers in clinical research in Malaysia. Opinion of the ONPR (Malaysian)

© 2021 Society of Regulatory Affairs Professionals.


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