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.
Final guidance issued by the US Food and Drug Administration clarifies and expands on how manufacturers of medical devices that come into contact with the human body should comply with the ISO 10993-1 standard for biological evaluation of devices within risk management frameworks.
ANVISA, Brazil’s medical device marker regulator, has announced plans to begin accepting electronic submissions of registration documents from manufacturers.
Publication of draft In Vitro Diagnostic Regulations (IVDR) in the European Union, which occurred earlier than anticipated, provides IVD manufacturers with a clearer idea of how new requirements will impact their CE Marking certification and compliance.
The China Food and Drug Administration (CFDA) has set a July 15, 2016 deadline for distributors of higher-risk medical devices to submit self-inspection reports.
European lawmakers and regulators have published eagerly awaited draft versions of new medical device and IVD regulations earlier than anticipated.
Governments of five Eurasian countries have issued final regulations to establish a harmonized regulatory system for medical devices and IVDs across their respective jurisdictions.
Emergo has received questions about precise timelines regarding the introduction of new European Medical Device Regulations. This indicates there is a strong need within the medical device community to get some indications as to the dates by which certain steps will be taken.
The US Food and Drug Administration has accepted 17 high-risk and de novo medical devices into an expedited access program launched in 2015, according to the agency.
Brazilian medical device market regulator ANVISA now accepts only electronic submissions of petitions for importation of devices.
In this second part of Emergo's analysis of the Medical Device Single Audit Program (MDSAP), we examine the current status of and challenges to the program as Australian, Brazilian, Canadian, Japanese and US regulators work towards implementation.