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's 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.

April 10, 2014 by Stewart Eisenhart
A new Health Canada report on regulatory inspections of domestic and foreign medical device companies active in the Canadian market has shown a 98% overall compliance rate among importers, manufacturers and distributors. Health Canada inspected a total of 2057 Medical Device Establishment License (MDEL) holders over the course of the regulator’s 2012-2013 fiscal year, citing 3251 observations of noncompliance with various sections of the Canadian Medical Device Regulations. Most common observations cited involved documentation issues (section 45(g) of the CMDR); recall procedures (section 58(b)); and investigation procedures (section 58(a)).
April 9, 2014 by Stewart Eisenhart
India’s drug and medical device market regulators will begin requiring importers to affix labeling information to their products before shipping to the country in September 2014. The Drugs Controller General’s (India) Central Drugs Standard Control Organization (CDSCO) currently requires “India-specific” labeling to be attached to imported devices at their Indian ports of entry by distributors. India-specific labeling information should include importer and/or distributor names and Import License numbers.
April 8, 2014 by Stewart Eisenhart
A new draft report by the US Food and Drug Administration proposes establishing a nationwide framework for regulating health information technology and medical devices. The FDA’s new proposals would involve three federal agencies (The FDA, Federal Communications Commission and the Office of the National Coordinator for Health Information Technology) in oversight of mobile medical apps and related technologies, and are intended to coordinate the roles of those regulators.
April 3, 2014 by Stewart Eisenhart
Canadian medical device market regulators have issued updated submission forms for Medical Device License (MDL) applicants.
April 1, 2014 by Stewart Eisenhart
The Brazilian government has implemented a new regulation, RDC 15/2014 (link in Portuguese), that significantly eases the registration process for certain low-risk medical devices and IVDs.
March 31, 2014 by Stewart Eisenhart
Emergo Group’s Beijing office reports that the Chinese government has published a new Medical Device Supervision Management Regulation (link in Chinese) covering the country’s medical device regulatory system. The new regulation will go into force June 1, 2014. Emergo Group is currently studying the new document to determine its impact on medical device manufacturers selling in the Chinese market. We will provide further analysis in the next issue of RADAR.
March 31, 2014 by Stewart Eisenhart
The European Commission has published its latest “Blue Guide” covering all products subject to the European Union’s New Legislative Framework, including medical devices, IVDs and active implantable devices. Emergo Group consultants in the US and Europe will be performing an extensive review of the new Blue Guide over the next several days, and will provide additional analysis of how medical device manufacturers will be impacted.
March 31, 2014 by Stewart Eisenhart
Costa Rican medical device regulators are preparing a system to facilitate online registration of medical devices in a move to drive up foreign manufacturers’ interest in the Central American market. The Costa Rican Ministry of Health has now published training materials for digital medical device registration, and is also conducting training sessions (link in Spanish) to explain the new process.
March 31, 2014 by Stewart Eisenhart
The Kingdom of Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has announced when medical device manufacturers must secure valid Medical Device Marketing Authorizations (MDMA) to legally continue selling their products in the KSA.
March 28, 2014 by Stewart Eisenhart
A recent presentation by the Japanese Ministry of Health, Labour and Welfare’s Medical Device Evaluation office has shed more light on planned  changes to the country’s medical device market regulatory system. According to Emergo Group’s Tokyo office, the changes include both high-level amendments to Japan’s Pharmaceutical Affairs Law (PAL) applicable to both medical devices and drugs, and also measures specifically geared toward medical devices.