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.

Saudi Regulators Update Requirements for Medical Device Shipments

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority has updated its policies for clearing medical device shipments at Saudi points of entry.
  • The revised requirements include changes to how long devices may be held at ports of entry according to shelf-life criteria.
  • Updates to declaration of conformity and related documentation requirements are also included.
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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.
Read more about Mexican Regulators Set Digital Advertising Recommendations for Medical Devices...

US FDA Recognizes ISO 18562 Biocompatibility Standard for Medical Devices

Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have officially recognized a series of ISO standards for volatile organic compounds (VOC) and particle testing as consensus standards.

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In Brief: South Korean Medical Device Information & Technology Assistance Center Changes Name

EMERGO SUMMARY OF KEY POINTS:

  • The South Korean Medical Device Information & Technology Assistance Center (MDITAC) is changing its name to the National Institute of Medical Device Safety Information (NIDS).
  • Functions and responsibilities of the division remain the same.
Read more about In Brief: South Korean Medical Device Information & Technology Assistance Center Changes Name...

US FDA Maps Out Pre-Submission Meeting Options for Medical Device Applicants

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance on how to utilize its Q-Submission Program for medical device manufacturers before they submit premarket applications.
  • Following MDUFA IV, FDA has revised scheduling and timeframe processes for the Q-Sub program.
Read more about US FDA Maps Out Pre-Submission Meeting Options for Medical Device Applicants...

Egypt’s CAPA to Require Registration for All Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Egyptian regulators will require registration for all medical devices starting in September 2018.
  • Currently only sterile devices fall under Egyptian CAPA oversight.
Read more about Egypt’s CAPA to Require Registration for All Medical Devices...

New US FDA Recommendations for Non-Clinical Bench Performance Test Submissions

EMERGO SUMMARY OF KEY POINTS:

  • US FDA issues recommendations for premarket test submissions regarding specific descriptions, inclusions, format, and report types.
  • Recommendations include structured outlines that encapsulate test motives that are to be included with each required Summary Report submission.
  • Specific FDA recommendations cover content and organization of complete Test Reports from overall description through conclusion.
Read more about New US FDA Recommendations for Non-Clinical Bench Performance Test Submissions...

US Regulators Plan Class II Reclassification of Diagnostic Imaging Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA plans down-classification of some diagnostic imaging devices for radiological applications.
  • Targeted devices would move from Class III (high risk) to Class II (moderate risk).
  • Affected devices would undergo 510(k) and special controls premarket review.
Read more about US Regulators Plan Class II Reclassification of Diagnostic Imaging Devices...

Singapore’s HSA Implements Major Medical Device Regulatory Changes

EMERGO SUMMARY OF KEY POINTS:

  • The Singaporean HSA has begun enforcing new regulatory changes for medical devices starting June 1, 2018.
  • The changes affect lower-risk devices, digital health technologies and high-risk devices such as implantable products.
  • HSA also plans to improve domestic and overseas post-market surveillance activities.
Read more about Singapore’s HSA Implements Major Medical Device Regulatory Changes...

US FDA Attempts to Spur Development of Medical Devices Targeting Opioid Addiction

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has launched a new program to fast-track development and market authorization of devices for treating opioid addiction and pain management.
  • Manufacturers have  until September 30, 2018 to submit applications to participate in the program.
  • Accepted manufacturers’ devices and technologies will undergo expedited premarket review.
Read more about US FDA Attempts to Spur Development of Medical Devices Targeting Opioid Addiction...

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