Regulatory News 2012
…some important regulatory changes and news in 2012
European Union
New Mandatory Requirements Determining Audit Time for ISO 13485
Effective July 15th 2012, the requirements determining the audit time have changed. This hast to be followed by all certification companies certifying quality management systems according to ISO 13485.
This means that for small and medium-sized companies up to 125 employees an increased audit time by round about 40 – 100 %!
…more info
The guidance MEDDEV papers have been updated in 2012
The European Commission has published the latest lists of MEDDEV guidance documents under…
MEDDEV 2.1/6
Qualification and Classification of stand alone software
MEDDEV 2.2/4
Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products
MEDDEV 2.5/10
Guideline for Authorised Representatives
MEDDEV 2.12-1
Medical Device Vigilance System
MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies
MEDDEV 2.14/1 rev.2
Borderline and Classification issues. A guide for manufacturers and notified bodies
MEDDEV 2.14/4
CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP
US FDA
FDA, Release of New Guidance: ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
FDA issued a new pilot program for a for ISO 13485:2003 Voluntary Audit Report Submission, which is effective since June 5, 2012.
The medical device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program outlined in this guidance is another way in which FDA may leverage audits performed by other foreign regulators and their accredited third parties in order to assist the agency in setting risk-based inspectional priorities.
Saudi Arabia
The regulation by the Saudi Food and Drug Authority (SFDA) for medical devices iis based on the Medical Devices Interim Regulation, which was issued in December 2008 and which requires products to be regulated throughout their lifecycle.
The SFDA is currently developing a comprehensive regulatory framework, which is expected to come into effect in 2016/2017.
The new regulatory framework will allow the SFDA to approve devices that are submitted to the authority for the first time and have not yet been approved by any other jurisdiction. Today, manufacturers who want to sell their medical device Saudi Arabia, must provide documents showing the product complies with the medical device regulations of at least one of the founding member jurisdictions of the Global Harmonization Task Force (Australia, Canada, Japan, the EU or the US).