Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Moody’s: US Medical Device Firms Face Soft Organic Growth Prospects

US medical device manufacturers dealing with lower market demand and rising pricing pressure will rely more on acquisitions and stock maneuverings to offset challenging growth prospects.

Moody’s Investor Service (via MarketWatch) anticipates slow sales for medical device firms over the next 12 to 18 months—especially for devices such as orthopedics used in elective procedures and cardiac products drawing more regulatory scrutiny due to safety and effectiveness concerns.

A weak global economy will necessitate share buy-backs, acquisitions and dividends by many firms in order to minimize losses, according to Moody’s. The ratings agency expects manufacturers to primarily borrow capital in order to fund such activities, which could negatively impact their credit standing.

Markets: USATags: cardiac, medical device, Moody's, orthopedics, US

Author: Stewart EisenhartDate: December 13, 2011

New US Reimbursement Policy Targets Some Medical Devices

A new Centers for Medicare & Medicaid Services (CMS) policy going into effect early next year will require prior authorization for some medical devices and equipment for Medicare patients in seven US states.

The new policy will also require pre-payment of reimbursement claims for some medical devices across 11 US states.

These reimbursement policy changes are intended to cut down on improper payments.

According to a Massdevice analysis of the new CMS policy, the new prior authorization requirements target 15 procedures, including pacemaker and defibrillator surgeries, spinal fusion procedures and joint replacements. These requirements will be implemented in two phases: During the first three to nine months of 2012, Medicare administrators will conduct prepayment reviews of certain medical equipment claims, followed by outright implementation of prior authorization requirements.

The prior authorization policy will affect Medicare recipients in California, Florida, Illinois, Michigan, New York, North Carolina and Texas. Claim pre-payment requirements will impact California, Florida, Illinois, Louisiana, Michigan, Missouri, New York, North Carolina, Ohio, Pennsylvania and Texas.

Markets: USATags: CMS, Medicaid, medical device, Medicare, reimbursement, US

Author: Stewart EisenhartDate: December 6, 2011

GHTF Moves to Disband

The Global Harmonization Task Force (GHTF), founded in 1992 to promote uniformity across medical device regulatory regimes, will soon cease to exist according to the Medical Technology Association (MTA) of Australia.

Regulators from the US, EU, Japan, Australia and Canada, the GHTF’s founding members, elected to dissolve the group in order to form a new entity consisting solely of regulators; in its current iteration, the GHTF allows equal standing for medical device industry associations. The proposed new organization will purportedly seek feedback from medical device industry advocates, health care representatives and consumer groups as part of ongoing regulatory harmonization pursuits.

The GHTF will continue in its current form at least until its next meeting in May, according to the MTA.