Worldwide medical device QA/RA blog

News and commentary on regulatory changes.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

Switzerland to Model Medical Device Regulations on European MDR Requirements

EMERGO SUMMARY OF KEY POINTS:

  • Swiss medical device market regulators are realigning their requirements to match those of the European MDR and IVDR.
  • Switzerland is revising its Medical Devices Ordinance (MedDO) using a staged approach, with completed revisions planned for 2020.
Read more about Switzerland to Model Medical Device Regulations on European MDR Requirements...

In Brief: Egypt Extends Registration Requirements for Non-sterile Medical Devices

Egyptian medical device regulators plan to require registration for moderate- and high-risk non-sterile devices starting April 1, 2018.

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FDA: GUDID Data Primarily from Class II and Implantable Medical Devices (So Far)

EMERGO SUMMARY OF KEY POINTS:

  • The FDA GUDID database now has more than 1.6 million records of medical devices registered for sale in the US.
  • Most GUDID data is from Class II devices, and almost half of GUDID records cover implantable devices.
  • So far, orthopedic devices account for 35% of GUDID device records.
Read more about FDA: GUDID Data Primarily from Class II and Implantable Medical Devices (So Far)...

New Guidance from China FDA on 3D Printed Medical Device Registration Rules

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration has issued draft guidance on regulatory requirements for 3D-printed medical devices.
  • The guidance proposes specific requirements for validation and related testing for additive manufacturing products submitted for CFDA approval.
  • A final version of the CFDA guidance will be published once stakeholder comments have been received and compiled.
Read more about New Guidance from China FDA on 3D Printed Medical Device Registration Rules...

Challenges When Designing a Mobile Medical App for Safe and Effective Use

When designing mobile applications for medical purposes, developers should keep the issue of safe and effective use top of mind.

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MDSAP Certification Route Extended to Brazilian, South American Medical Device Companies

EMERGO SUMMARY OF KEY POINTS:

  • Brazilian regulators now allow domestic manufacturers to apply for quality system certification under the Medical Device Single Audit Program (MDSAP).
  • Previously, ANVISA’s position was to recognize MDSAP certification only for foreign manufacturers.
Read more about MDSAP Certification Route Extended to Brazilian, South American Medical Device Companies...

Indian Regulators Issue FAQ on Medical Device Rules

EMERGO SUMMARY OF KEY POINTS:

  • A new FAQ from the Indian CDSCO addresses several questions regarding compliance with the new Medical Device Rules 2017.
  • Issues covered in the FAQ include status of medical device registration applications still under review at CDSCO, notified medical device listing changes and standards compliance.
  • India’s Medical Device Rules 2017 went into effect in January 2018.
Read more about Indian Regulators Issue FAQ on Medical Device Rules...

US FDA Rolling Out Updates to UDI Database in 2018

EMERGO SUMMARY OF KEY POINTS:

  • US FDA plans updates to its Global Unique Device Identification Database (GUDID) for Spring and Summer 2018.
  • GUDID updates include new file data elements, record accessibility and premarket submission and supplement number requirements.
Read more about US FDA Rolling Out Updates to UDI Database in 2018...

Eudamed Accessibility for Non-European Authorities

EMERGO SUMMARY OF KEY POINTS:

  • Some information in Eudamed will be publicly accessible.
  • Typically, non-European authorities only have access to publicly available Eudamed data.
  • The MDR and IVDR keep the option open for non-European countries to exchange data with Eudamed and have access to data that is not publicly accessible, based on reciprocity.
  • The European Commission has indicated IMDRF members of the NCAR system will be the first to get extended access.
  • Eudamed could be a new world standard in data exchange regarding device safety.
Read more about Eudamed Accessibility for Non-European Authorities...

Brazilian ANVISA Clarifies Local, Federal Level Medical Device Oversight Responsibilities

EMERGO SUMMARY OF KEY POINTS:

  • ANVISA has formally mapped out medical device regulatory responsibilities at its federal, state-level and local branches.
  • Under RDC 215/2018, ANVISA oversight responsibilities and structures currently in place are mostly kept as is.
Read more about Brazilian ANVISA Clarifies Local, Federal Level Medical Device Oversight Responsibilities ...

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