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Emergo by UL 인허가 요약: 2018년 11월 글로벌 트렌드

이것은 글로벌 의료기기 인허가 업데이트의 두 번째 내용이자 글로벌 트렌드와 관련한 자료입니다. 지난 몇 달간 (2018년 7월-11월), 글로벌 트렌드를 뒷받침하는 관찰 데이터를 수집했습니다. 무엇이 트렌드를 구성하는지에 대하여 냉철하게 분석하여, 전문적인 판단을 통해 다음과 같은 주제에 대해 확인했습니다.

  • 기기 추적 및 추적 가능성을 강화하는 계획,
  • 의료기기 단일 심사 프로그램 또는 MDSAP(캐나다 보건국이 새로 유연성 정책을 발표했음에 유의) 활동의 증가,
  • 위험이 가장 적은 의료기기를 위한 인허가 과정 단순화 제안

IMDRF는 의료기기 규제기관 사이의 조화를 계속 추구하여, 이러한 맥락으로 해당 계획의 기간을 설정합니다.

글로벌 시판 후 감시(PMS): 기기 추적 가능성 및 추적

전 세계적으로 총 제품 라이프사이클 데이터의 수집, 시장에 공급되는 기기에 대한 명확한 데이터 수집을 가능하게 하는 디지털 및 인허가 계획에 대한 관심이 계속되고 있습니다.

IMDRF Targets Uniform Standards for Medical Device Auditors

The International Medical Device Regulators Forum (IMDRF) has published new recommended requirements for recognizing device company auditors ahead of an international auditing program pilot launching this year in the US, Canada, Brazil and Australia. Separately, the IMDRF has issued final documents on related topics including auditor training requirements, Unique Device Identification (UDI) and software as a medical device.

IMDRF Proposes Convergence on Stand-Alone Software Regulation

The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force (GHTF), is seeking comment through August 2013 on proposed definitions of standalone medical device software. The IMDRF sees these definitions as a first step toward establishing an international framework for more uniform regulatory approaches to medical software.

Hospitalar 2013: ANVISA Plans Trial Period for 3rd Party B-GMP Audits

During the annual Hospitalar medical device and technology conference in Sao Paolo, Emergo Group learned that Brazilian medical device market regulator ANVISA plans to launch a two-year trial period to allow third-party audits of Brazilian Good Manufacturing Practice (B-GMP) quality systems.

ANVISA has set a tentative start date of January 2014 for the trial; the US, Canada, Brazil and Australia are expected to participate, meaning that third-party certifiers would be able to audit a manufacturer’s quality system for US, Canadian, Brazilian and Australian requirements at the same time.

IMDRF Issues Draft Criteria for Medical Device Auditing Organizations

The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force, has proposed draft criteria for use by medical device market regulators to recognize qualified auditing organizations.

The draft proposal targets auditing processes conducted as part of conformity assessments as well as of post-market surveillance procedures; IMDRF members aim to establish a common list of criteria regulators can use to recognize or designate entities performing auditing services that cover medical device manufacturers. If adopted, the criteria could drive greater uniformity and efficiency in medical device quality system audits across global medical device markets.