North America - Aug/Sep 2018

  • Canada: Further reductions to MDSAP audit durations have been announced for small companies

  • Canada: Health Canada is adopting the Global Medical Device Nomenclature (GMDN)

  • Canada: Down classification of artificial larynx devices into Class I

  • Canada: Comments sought on Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals)

  • USA: Next generation sequencing based tumour profiling test is classified into Class II

  • USA: Class II classification for the brain trauma assessment test

  • USA: Fluid jet system for prostate tissue removal classified into Class II and subject to a 510(k)

  • USA: Class II classification assigned to the endoscopic electrosurgical clip cutting system

  • USA: In vivo cured intramedullary fixation rod classified as Class II

  • USA: Microneedling device for aesthetic use classified into Class II

  • USA: Class II classification for blood establishment computer software (BECS) and its accessories

  • USA: Sharps needle destruction devices down-classified into Class II

  • USA: Exemption from pre-market notification for five types of Class II medical devices

  • USA: Certain Class II surgical apparel now exempt from pre-market notification

  • USA: Changes proposed to update the product jurisdiction regulations

  • USA: Proposed reclassification of medical image analysers from Class III to Class II

  • USA: Alternative or streamlined mechanisms for complying with the cGMP requirements for combination products

  • USA: Medical product communications that are consistent with the FDA-required labelling; guidance for industry

  • USA: Logical observation identifiers names and codes (LOINC) for IVD tests

  • USA: Updated guidance drafted on the Q-Submission programme

  • USA: Consultation underway on draft guidance concerning 510(k) submissions for metal expandable biliary stents

  • USA: Guidance drafted on recommended content and format of complete test reports for non-clinical bench performance testing

  • USA: Draft guidance issued on the policy and considerations for multiple function device products

  • USA: Draft guidance documents on recommended pre-market testing and labelling for intravascular catheters, guidewires and delivery systems

  • USA: Common questions on the HDE programme addressed in new draft guidance

  • USA: Quality System Regulation to be aligned with ISO 13485:2016

  • USA: ‘Innovation challenge’ launched to support development of novel medical devices to help combat the opioid crisis

  • USA: Modifications to the list of US FDA-recognised standards

Click here for the full article on Global Regulatory Press.

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