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.

July 21, 2014 by Stewart Eisenhart
Roszdravnadzor, the Russian medical device market regulator, has announced plans (link in Russian) to develop a new device classification system based on Global Medical Device Nomenclature (GMDN), suggesting perhaps a regulatory approach more harmonized with international standards than previous Russian registration requirements.
July 18, 2014 by Stewart Eisenhart
New Zealand medical device and drug market authority Medsafe has updated its process for defining medical devices and pharmaceutical products as part of an ongoing merger with the Australian Therapeutic Goods Administration.
July 16, 2014 by Stewart Eisenhart
New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device registration and clinical trial regulations. First, CDSCO has reiterated 14 categories of devices that do fall under India’s Drugs and Cosmetics Act and qualify for regulation:
July 16, 2014 by Stewart Eisenhart
New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make Substantial Equivalence (SE) determinations.
July 10, 2014 by Stewart Eisenhart
Medical device market regulators in Malaysia have amended their Declaration of Conformity (DoC) and Additional Information Request requirements for manufacturers registering their products in the country.
July 7, 2014 by Stewart Eisenhart
Mexican medical device market regulator COFEPRIS has recently confiscated 23,000 medical devices due to improper labeling, according to Emergo Group sources in Mexico City. Specifically, the devices were seized for noncompliance with Mexican labeling norm NOM-137-SSA1-2008 requirements. Violations included:
June 27, 2014 by Stewart Eisenhart
Canadian medical device market regulators have issued a draft notice on plans to implement a national Unique Device Identification (UDI) system based solely on guidelines developed by the International Medical Device Regulators Forum (IMDRF). Health Canada states that it does not plan to add any additional UDI requirements specific to the Canadian market “at this time,” relying completely on the IMDRF UDI Working Group’s finalized guidance issued in December 2013.
June 26, 2014 by Stewart Eisenhart
Medical device data systems (MDDS) used to support digital health technologies will no longer be required to comply with the US Food and Drug Administration’s regulatory controls, according to new guidance from the agency.
June 20, 2014 by Stewart Eisenhart
Requirements that medical device companies based in Malaysia obtain establishment licenses will come into force on June 30, 2014. Following that deadline, any medical devie manufacturer, authorized representative or distributor that has not either obtained or applied for a device license may not conduct medical device-related business in Malaysia.
June 19, 2014 by Stewart Eisenhart
Following third-party process improvement recommendations issued in late 2013, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has laid out a two-stage plan to implement those changes for medical device reviews.