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.

2012年 5月 2日

Nouvelles réglementaires d'Australie

Des réformes se sont mises en place dans la réglementation des dispositifs médicaux. Des prothèses articulaires défectueuses ont récemment causé une vive inquiétude en Australie. En réponse, le gouvernement mettra en œuvre un certain nombre de modifications dans la réglementation des dispositifs médicaux.
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2012年 5月 2日

Reforms taking place in the regulation of medical devices in Australia

Faulty joint replacement implants have been the subject of much concern in Australia recently. In response, the Government will implement a number of modifications in the regulation of medical devices.
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2012年 5月 1日

GHTF Proposes Standardized Approach to QMS Nonconformity Issues

The Global Harmonization Task Force (GHTF) has proposed establishing a standardized grading system for quality management system (QMS) nonconformities , along with a standardized Regulatory Audit Information Exchange Form to provide more consistent ISO 13485:2003 audit data for use between medical device market regulators. The GHTF’s proposed Regulatory Audit Information Exchange Form includes three parts. First, a list of nonconformities from a QMS audit report is necessary to explain each nonconformity reported. (The nonconformities included in this list should match those listed in the manufacturer’s original audit report.)
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2012年 4月 24日

Legislation to Establish Medical Device Regulatory Framework Advances in Malaysia

New laws setting up a formal regulatory system for medical devices have been approved by the Malaysian government, according to Med/Cert.
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2012年 4月 23日

Singapore Eases Market Entry for Lower-Risk Devices

In a move likely to boost interest in the Singaporean medical device market, the Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to implement new rules effective May 1 to provide expedited market access for lower-risk devices .
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2012年 4月 20日

EU Labeling, Vigilance and EN 60601-1 News

Guidance on CMC labeling decision As we mentioned last year, the Central Management Committee (CMC) on Medical Devices made a decision in 2011 that affects labeling for manufacturers and
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2012年 4月 18日

New IVD Regulations Imminent in Brazil

The new regulation will change the classifications of Class I, II, III and IIIa IVD devices to Class I, II, III and IV. IVD reclassifications will be more aligned with Global Harmonization Task Force risk-based classification criteria.
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2012年 4月 16日

Health Canada Amends Lists of Medical Device Standards

Health Canada has announced changes to its list of recognized list of medical device
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2012年 4月 16日

CDSCO Expanding to Enforce New Clinical Trial Rules in India

Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
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2012年 4月 9日

FDA Lists Final Guidance on 513(g) Requests for Information

The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.
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