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.

2011年 8月 4日

JFMDA Pushing for More Flexible Accreditation System in Japan

The Japan Federation of Medical Device Associations (JFMDA) has filed a petition with the country’s Ministry of Health, Labour and Welfare as well as the Pharmaceutical and Medical Devices Agency (PMDA) arguing for more flexible accreditation requirements for foreign device manufacturers that move factories or change names due to mergers or acquisitions.
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2011年 8月 15日

FDA Draft Guidance Identifies Benefit-Risk Factors Used for Premarket Reviews

The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications. In making these factors public, the regulator hopes to improve predictability, consistency and transparency of its PMA process (as well as some 510(k) reviews).
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2011年 8月 15日

Health Canada Proposes Risk-Based Inspection Model

Health Canada is seeking comment from industry on a proposed risk-based inspection model for medical...
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2011年 8月 18日

FDA Proposes Longer Post-Market Surveillance Requirements for Pediatric Devices

New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding
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2011年 8月 18日

August 23rd Deadline for FDA Final Rule on Three Obsolete Class III Devices

A final FDA rule affecting ventricular bypass devices , pacemaker repair or replacement material
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2011年 8月 29日

FDA Recommends Risk-Based Approaches to Monitoring Clinical Investigations

New guidance from the US Food and Drug Administration recommends investigational device exemptions (IDEs) and Investigational New Drugs (INDs).
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2011年 8月 30日

New Saudi Regulations in Effect for Medical Device Importers

Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.
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2011年 9月 1日

FDA: PMA Requirements for Surgical Mesh Devices Possible

The US Food and Drug Administration appears likely to require premarket assessments rather than premarket notifications for surgical mesh devices used to treat pelvic organ prolapse (POP) but not for stress urinary incontinence (SUI) in women.
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2011年 9月 2日

New Manufacturer Evaluation Codes in Place at FDA

New Manufacturer Evaluation Codes for use in medical device reports have been established by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
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2011年 9月 8日

AdvaMed Study: Medical Device Excise Tax Would Be Terrible

A new study funded by US medical device industry lobbying group AdvaMed anticipates job losses,...
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