International Medical Device Regulatory Monitor

The European Commission (EC) has published a final guideline aimed at clarifying the relationship between devicemakers and their authorized representatives (AR). Includes the full text of EU Guideline on Role of Authorized Representatives.

Devicemakers can expect quality system audits to include a review of their postmarket surveillance procedures, including plans for any required clinical follow-up studies, according to a new European Commission guideline.

Clinical trial sponsors and sites have less than a month before the U.S. Food and Drug Administration (FDA) begins enforcing a new rule that requires informed consent documents to include a specific statement that trial information will be made public on ClinicalTrials.gov.

The Global Harmonization Task Force’s (GHTF) Study Group 5 has released a proposed guidance on clinical performance studies for in vitro diagnostic (IVD) devices.

The European Commission has published a final guideline aimed at clarifying borderline and classification issues related to in vitro diagnostic (IVD) devices.

Africa represents a significant market opportunity for medical devicemakers. But success hinges on understanding each market a company decides to enter.

Kenya’s Pharmacy and Poisons Board (PPB) has issued guidance on the documentation devicemakers and their local authorized representatives must submit in order to register a product there.

Australia and New Zealand will begin sharing device and drug good manufacturing practice reports shortly, with the aim of establishing joint GMP audit capability by early 2013 — part of a much larger plan to merge the countries’ health products regulatory authorities.

Patient outcomes should be one of the guiding principles of any pricing framework for activity-based funding of Australian public hospitals, the country’s device industry says.

The nonprofit group Regulatory Harmonization International (RHI) has launched an educational initiative aimed at bringing South Korea-made healthcare products to the U.S. market.

The U.S. Food and Drug Administration plans to begin triaging premarket submissions April 1, in an effort to improve efficiency and strengthen premarket reviews.

Lawmakers on both sides of the aisle hammered the U.S. Food and Drug Administration’s (FDA) failure to reduce device approval times, with at least one lawmaker saying he would end the user fee program if “significant reforms” aren’t undertaken.