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 3月 16日

FDA Publishes Changes to Premarket Review Standards

Effective March 8, the US FDA has issued modifications to the list of standards used...
阅读更多
2011年 3月 21日

JFMDA Urges Prioritization of Power Allocation to Meddev Manufacturers

The Japanese government should prioritize power supply allocation to medical device manufacturing facilities producing life-saving and sustaining devices such as ventilators, oxygen supply products an
阅读更多
2011年 3月 23日

Eucomed: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation. Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions , following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs.
阅读更多
2011年 3月 25日

CDRH Updates Import Entry Review Process for Medical Devices

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued recommendations to improve
阅读更多
2011年 3月 25日

Important US FDA Import Recommendations

The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of th
阅读更多
2011年 3月 28日

Health Canada Moving to Flat-Fee Structure April 1st

Citing rising costs of performing medical device and pharmaceutical regulatory activities in Canada, Health Canada has announced user fee increases—some of them substantial—for medical device license
阅读更多
2011年 3月 30日

AdvaMed, MDMA Pursue Different Approaches to Pending Medical Device Excise Tax

The medical device excise tax provision passed last year as part of the Patient Protection and Affordable Care Act in the US has drawn heavy fire from industry groups, with entities such as the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) pushing for either clarification of how the rule will be implemented and enforced or for outright repeal of the tax. Set to go into effect in 2013, the rule in question would levy a 2.3% tax on all medical device manufacturers' US sales revenues.
阅读更多
2011年 3月 30日

JFMDA Pushes for Industry-Specific Regulatory Framework

The Japan Federation of Medical Device Associations (JFMDA) has begun pushing for regulations specifically targeting the medical device industry ahead of plans next year to revise the country’s Pharma
阅读更多
2011年 3月 30日

Affirmations of Compliance Codes (AofC Codes)

According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes.
阅读更多
2011年 3月 30日

Expediting Customs Clearance with AofC Codes

The FDA recently issued a Letter to Industry with recommendations for using Affirmation of Compliance (AofC) codes to expedite release of goods from US Customs and Border Protection (CBP) for imported medical devices. Use of the AofC codes is voluntary but recommended to avoid Customs delays. According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes. We have listed some of the most commonly used AofC codes here .
阅读更多

Pages