Worldwide Medical Device Regulatory Updates
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.
The Health Science Authority (HSA), Singapore’s medical device market regulator, will begin publishing field safety corrective action (FSCA) information on its website to boost public awareness of risk and safety issues involving devices legally sold in the country.
Advisors to the Indian government have proposed adding certain product types to the country’s list of notified devices, as well as implementing high-level quality management system requirements for medical devices manufactured and registered for sale in the country.
Brazilian medical device market regulator ANVISA has formally recognized a program whereby the agency will accept quality system certifications from US, Canadian and/or Australian regulators in order to register devices from foreign manufacturers for sale in the country.
New regulations published by Brazilian medical device market regulators will simplify some aspects of Class I and II device as well as IVD registrations, but also introduce some new requirements for these market applicants.
On 19 June 2015 the Council of Ministers of the European Union decided on its “general approach” for the new Regulations for medical devices and IVDs.
The US Food and Drug Administration has revised fees the agency charges for issuing medical device export certificates in response to higher costs and demands for these documents.
Citing security vulnerabilities, the US Food and Drug Administration has extended deadlines for compliance with a key component of the agency’s Unique Device Identification (UDI) system.
A new report released by the US Food and Drug Administration shows a substantial reduction in instances where incomplete premarket applications are refused under the agency’s Refuse to Accept (RTA) policy, as well as decreases in overall review timeframes for medical device clearances and approvals between 2010 and 2014 fiscal years.
Canadian medical device market regulator Health Canada now requires all Class II Medical Device License (MDL) applicants to include labeling information in their submissions.
The Chinese Food and Drug Administration (CFDA) has published new guidelines covering technical review components of medical device software registration.