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 Medical Device Authority (MDA), Malaysia’s medical device market regulatory agency, has extended its deadline for temporary expedited device registrations to June 30, 2016.
The US Food and Drug Administration has finalized plans to exempt some “well understood” Class I and II medical devices from 510(k) premarket notification requirements, according to new guidance from the agency.
Malaysia’s Medical Device Authority (MDA) has issued two new sets of guidelines establishing post-market reporting and corrective action requirements for devices sold in the country.
New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to medical devices intended for reprocessing and reuse.
In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the US Food and Drug Administration has published new guidance explaining key issues the agency uses to assess benefits and risks of IDE submissions for clinical investigations of Class III and some Class II medical devices.
New rules issued by medical device market regulators in the Kingdom of Saudi Arabia require new barcodes for some types of devices registered for sale in the KSA.
Brazil’s medical device market offers significant growth potential for foreign manufacturers, but the country’s device approval process is challenging.
Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.
DIGEMID, Peru’s medical device market regulatory agency, has rolled out new disclosure and labeling rules for medical devices that contain polyvinyl chloride (PVC) or PVC that contains DEHP (di-(2-ethylhexyl)phthalate).
During the 2015 Hospitalar medical technology trade show in Sao Paolo, Brazilian medical device market regulator ANVISA provided an update on its participation in the international Medical Device Single Audit Program (MDSAP).