International Medical Device Regulatory Monitor

The International Medical Device Regulators Forum last month unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices.

A draft report from the EU Parliament’s health committee calling for centralized authorization of novel Class III medical devices stunned industry groups that have pushed for more measured reforms to medical device regulations.

The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.

In vitro diagnostic manufacturers can expect a “quantum leap” in regulatory burden if the European Commission’s proposed IVD regulation is adopted — a 180-degree turn in notified body requirements, a device legal expert says.

Device trade groups are pushing for several harmonization provisions, including a single-audit system, to make it into the planned Transatlantic Trade and Investment Partnership (TTIP) Agreement.

A final agreement for a Trans-Pacific Partnership (TPP) should establish a fair, predictable process for medical device reimbursement, AdvaMed says.

The China Food and Drug Administration (CFDA) has drafted two measures aimed at expediting approval processes for medical devices.

The use of a proposed trans-Tasman early warning system for devices and drugs should be limited to generic problems and when sponsor or manufacturer communications have been deemed ineffective, the Medical Technology Association of Australia (MTAA) says.

The Philippines Food and Drug Administration last month adopted a harmonized adverse event reporting system for defective or unsafe medical devices and other FDA-regulated products.

Australian devicemakers are asking the government to include guidelines specifically covering mobile medical apps and apps for health and wellbeing in any policy on mobile privacy.

New proposed Australian legislation intended to bring sunshine to financial transactions between drugmakers and physicians has medtech groups concerned about future inclusion.

Oral arguments are set for May 15 in a suit pending in the D.C. Circuit Court of Appeals that seeks to overturn the U.S. Securities & Exchange Commission’s (SEC) conflict minerals disclosure requirement.