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medical device advertising

New Law in France Targets Advertising of High-Risk Medical Devices

On 1 January, 2013 France implemented a new law which regulates the advertisement of several high-risk medical devices and IVDs to healthcare professionals. The new law also applies to dermal fillers and IVDs (intended for self-testing) that are advertised to the public. Devices falling under the new law include cardiovascular implants, coronary and intracranial stents, and breast implants.

Australian TGA Seeks Broader Penalty Powers for Medical Device Advertising Violations

EMERGO SUMMARTY OF KEY POINTS:

  • The Australian Therapeutic Goods Administration (TGA) is seeking additional sanction and penalty powers against medical device and drug companies violating advertising rules.
  • Proposed sanction and penalty tools would allow punishments more commensurate with severity of advertising violations.

TGA will erweiterte Durchsetzungsbefugnisse bei der Ahndung von Verstößen gegen Werbevorschriften

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO:

  • Die australische Therapeutic Goods Administration (TGA) will mehr Befugnisse zur Ahndung von Medizinprodukte- und Arzneimittelunternehmen, die gegen die Werbevorschriften verstoßen.
  • Die vorgeschlagenen Sanktionen würden den Verstößen gegen diese Vorschriften besser entsprechen.

Australian TGA to Take Over Medical Device Advertising Complaint Oversight in 2018

EMERGO SUMMARY OF KEY POINTS:

  • Australian advertising complaint oversight for medical devices and drugs will be consolidated under the Therapeutic Goods Administration.
  • Full TGA oversight will begin in July 2018.
  • Additional advertising requirement reforms for medical devices are planned for 2018.

Australische TGA: ab 2018 Aufsicht über Beschwerden in Bezug auf Werbung für Medizinprodukte

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO:

  • Die Therapeutic Goods Administration übernimmt die Aufsicht über Beschwerden in Bezug auf Werbung für Medizinprodukte und Arzneimittel.
  • Die TGA wird die Aufsicht ab Juli 2018 übernehmen.
  • Weitere Vorschriften für die Werbung für Medizinprodukte sind für 2018 geplant.

Mexican Regulators Set Digital Advertising Recommendations for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Mexico’s COFEPRIS has issued simplified guidelines for medical device digital advertising campaign processes.
  • The guidelines cover proprietary content developed by manufacturers as well as third-party content disseminated via social media channels.