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International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor

December 2014

Vol.: 22
No. 12

Headlines

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CDSCO, Industry Each Take Stab At Improving Quality of Devices

December 16, 2014
India’s Central Drug Standards Control Organization has issued a draft guideline on good manufacturing practices for medical devices and diagnostics — the latest in an effort to increase the quality of medtech products, which are governed loosely under the country’s drug laws. Read More

Canada’s New Product Safety Law Could Jeopardize Trade Secrets

December 16, 2014
A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers because it also allows for the release of confidential business information on unsafe products. Read More

UK Announces Major Review to Speed Devices to Market

December 16, 2014
The British government is conducting a massive review of how new medical devices and in vitro diagnostics are developed, with the aim of bringing products to market faster and speeding patient access. But some observers say the initiative should be broader and also include reforms in national reimbursement policy. Read More

Guidance Clarifies Notified Body Requirements for Device Changes

December 16, 2014
Changes to a medical device’s software, in most cases, require notified body review and acceptance prior to release in the European market to ensure the safety and wellbeing of patients and caregivers, according to best practice guidance developed by the European Commission. Read More

RoHS 2: One Company’s Efforts to Comply With New Rules

December 16, 2014
Three months after the EU’s RoHS 2 deadline, U.S. devicemaker Stryker has reviewed more than 600 products and dealt with “significant” costs to comply with the regulations. Despite the onerous mandate, the company says it has had a relatively easy time finding alternative components when needed. Read More

China, U.S. to Cut Tariffs on IT Medical Devices

December 16, 2014
Import duties on a range of IT products, including some high-tech medical devices, would be eliminated under a breakthrough agreement reached Nov. 10 by China and the U.S. The agreement paves the way for World Trade Organization members to broker a similar deal across more markets. Read More

Class III, PMAs for Flexible Pedicle Screws Proposed in U.S.

December 16, 2014
The U.S. Food and Drug Administration plans to tighten restrictions on dozens of spinal screws already on the market, requiring new PMAs for dynamic stabilization systems that are used to treat severe spondylolisthesis, fracture, dislocation, scoliosis and spinal tumors. Read More

Think Tank: U.S. FDA Off-Label Sharing Rules Too Restrictive

December 16, 2014
Recent U.S. Food and Drug Administration guidance on distributing scientific publications that cover off-label uses is out of touch with today’s data-driven economy and should be modified to embrace digital communication platforms, a Washington, D.C., think tank says. Read More

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