International Medical Device Regulatory Monitor

Simplifying Global Compliance

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December 2014

Vol. 22

No. 12

Headlines

Full Issue of International Medical Device Regulatory Monitor in PDF Format

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CDSCO, Industry Each Take Stab At Improving Quality of Devices

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

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

Panel Cites Lack of Safety Data on DEHP, Alternative Materials

The European Commission is again seeking to calculate the potential risks of the plasticizer di(2-ethylhexyl) phthalate in medical devices, saying there is a dearth of conclusive data to support limiting its use. Read More

UK Announces Major Review to Speed Devices to Market

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

Groups Push for More Harmonized Approach to Technology Assessments

A voluntary network of European health technology assessment bodies is calling for greater cooperation among HTAs to avoid duplicating work related to medical device coverage decisions in individual EU countries. Read More

Guidance Clarifies Notified Body Requirements for Device Changes

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

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

IMDRF Compiles List of Standards for Use as Harmonization Tool

The International Medical Device Regulators Forum has published a final report on international standards to be used by regulatory authorities in harmonizing regulatory requirements. Read More

Aussies, Kiwis Scrap Efforts on Joint Regulatory Agency

Australia and New Zealand have abandoned plans for a joint drugs and devices regulatory authority, although both countries say they will continue to cooperate on mutually beneficial regulations. Read More

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

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.

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

U.S. FDA Sees 15 Percent Bump in Regulatory Restrictions

U.S. Food and Drug Administration regulations have gotten lengthier and more prohibitive, with the number of regulatory restrictions up 15 percent since the turn of the century, new data show. Read More

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

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