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 China Food and Drug Administration (CFDA) has issued two new draft lists of medical devices to exempt from clinical trial requirements.
While Brazil’s political scene has taken a turn for the dramatic in recent weeks, the country’s medical device sector has seen its own share of excitement over steep registration fee increases (and reversals), MDSAP participation and related issues.
The transition period for medical device registrations in Malaysia is coming to a close, after which Malaysian market applicants will have to submit substantially more paperwork to regulators in order to obtain registration.
Final guidance from the US Food and Drug Administration explains post-market surveillance requirements that pertain to certain types of medium- and high-risk medical devices sold in the US.
New draft guidance from the US Food and Drug Administration covers premarket and quality system issues concerning medical devices incorporating additive manufacturing (AM), or 3-D, printing and fabrication techniques.
This is part one in a series of blog posts Emergo will be publishing during 2016 discussing the rollout of ISO 13485:2016 and how companies can prepare.
Health Canada, the Canadian medical device market regulator, plans to extend its deadline for commercially reprocessed devices to obtain Medical Device and Medical Device Establishment Licenses and meet market authorization requirements, according to the agency.
Malaysian medical device regulators have exempted all low-risk Class A medical devices from premarket review requirements, simplifying market access for these products.
As we wrote earlier, European Regulations for Medical Devices and IVDs are still in their “First Reading” stage. In order to come to the formal First Reading document, the European Parliament, the Council and the European Commission are now negotiating under the Dutch EU-presidency.
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), is planning a new good distribution practice standard for medical devices that requires licensure of companies importing and supplying devices in the country.