International Medical Device Regulatory Monitor

A group of medical device experts from EU member states would oversee device regulation in the union, according to one proposal in a recent “roadmap” released by the European Commission’s Directorate-General for Health & Consumers.

Malaysia’s Medical Device Control Division (MDCD) has issued a series of companion draft guidances on in vitro diagnostic (IVD) medical devices in anticipation of a new device regulatory regime set to take effect in December 2012.

A public-private partnership hopes to speed novel medical devices from development to market penetration in Ontario by identifying needed improvements before the premarket approval phase.

The Global Harmonization Task Force’s (GHTF) Study Group 2 recommends a three-tiered classification system for field corrective actions (FCAs), according to draft guidance.

Australian devicemakers are criticizing a Therapeutic Goods Administration (TGA) report on regulatory reform that fails to endorse a common industry conduct code.

Medical device advisory committee members should disclose any potential conflict of interest prior to each meeting, according to a final guideline by Australia’s Therapeutic Goods Administration (TGA).

The Tanzania Food and Drugs Authority (TFDA) requires formal reports for serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) in clinical trials conducted in the country, according to a draft guideline for sponsors, investigators and contract review organizations.

Whether it’s regulatory reforms in the U.S. and Australia, new regulatory frameworks in emerging economies, regulatory guidances and harmonization activities or medtech taxes by cash-strapped governments, IMDRM spanned the globe in 2011 to bring readers useful, up-to-date information on international medical device regulations. As we move into 2012, here are some of the challenges for the year ahead. Use this overview to ensure your success in the U.S. and abroad.

If a newly submitted bill is passed into law, it could force devicemakers to conduct more postmarket studies after 510(k) clearance.

For some devices, laboratory testing and computer modeling may offer better product review data than clinical trials, a U.S. Food and Drug Administration (FDA) official said.

Devicemakers responding to unsolicited requests for off-label product information are urged to keep conversations private and specific to the requester’s inquiry, according to a new draft U.S. Food and Drug Administration (FDA) guidance.

In response to a citizen petition, the U.S. Food and Drug Administration (FDA) is seeking public input on how it should regulate scientific exchanges on off-label uses for medical products.

The U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations.