-
Mobile Medical Applications
Post date: 03/12/2012 - 4:57pm
Looking for the best pizza in town? There’s an app for that. Need driving directions to the restaurant? There’s an app for that. Want to send the reading from your glucose meter to your doctor after...
-
New MEDDEV Guidelines on Postmarket Clinical Follow-Up Studies
Post date: 03/12/2012 - 4:49pm
In addition to MEDDEV 2.7.1 rev.3, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies,” that was published in December 2009, a new document (MEDDEV 2.12-2 rev.2) has been published,...
-
Singapore’s New Device Regulatory Framework
Post date: 03/12/2012 - 4:45pm
The Singapore Health Sciences Authority (HSA) passed the Health Products Act in February 2007 to improve the regulatory control of medical devices in Singapore. This was a fundamental change in the...
-
Understanding the Infusion Pump Crisis
Post date: 03/12/2012 - 4:41pm
The use of smart infusion pumps has become ubiquitous in many U.S. and international clinical settings due to the tremendous patient benefits these devices offer. Briefly, infusion pumps are medical...
-
Regulation of Laboratory-Developed Products: What Next?
Post date: 01/12/2012 - 3:26pm
FDA continued its march to restrict or regulate laboratory-developed tests (LDTs). Even though the recently issued draft guidance, “Commercially Distributed In Vitro Diagnostic Products Labeled for...
-
Western Diseases Are Now More Rampant in Asia
Post date: 01/12/2012 - 3:37pm
In many Asian countries, rapid economic growth during the past decade has led to increased personal incomes, improved public healthcare, and longer life expectancies. At the same time, an aging...
-
French Tax on Medical Devices to Be Paid by Distributors, Not Manufacturers
Post date: 01/12/2012 - 3:44pm
A tax on the sale of medical devices and IVDs was introduced in 2001 by AFSSAPS, the French competent authority. This tax was levied at 0.25% of the annual sales in France made by a manufacturer (...
-
Tips to Prepare for an FDA Inspection by Learning from Others Misfortunes
Post date: 01/12/2012 - 3:48pm
If a company is selling medical devices in the United States, it knows it will eventually undergo an FDA inspection in its future, even if it has had one in the past. Like most people, the company...
-
The Future of Healthcare is Going to be More Personalized and More Regulated
Post date: 11/16/2011 - 2:53pm
The summer of 2011 revealed a potentially historic breakthrough in medicine: MIT’s broad-spectrum antiviral therapeutics. It is a real breakthrough, although it has only been tested in the laboratory...
-
Misconceptions of FDA’s Device Electronic Records Regulations
Post date: 11/15/2011 - 2:09pm
On March 20, 1997, FDA promulgated “21 CFR Part 11: Electronic Records; Electronic Signatures; Final Rule” in the Federal Register, along with a significant preamble guidance to address the scope of...
-
Indonesia Medical Device Update
Post date: 11/15/2011 - 2:07pm
The Indonesian economy has been strong recently, and its GDP should continue to grow at about 5-7% during the next few years. The economy is bolstered by strong exports and increasing investments....
-
Full Manufacturer Addresses on Medical Device Labels?
Post date: 11/15/2011 - 1:58pm
The Medical Devices Expert Group, the Notified Bodies Group, the Notified Body Operations Group, the Medical Devices Competent Authorities Meetings, and working groups of the EU commissions...
-
New FDA MDDS Regulation: Fix or Folly?
Post date: 09/14/2011 - 1:16pm
FDA promulgated the Medical Device Data System (MDDS) regulation in the Federal Register on February 15, 2011 to address the regulatory status of systems and software that, for example, interface...
-
Latest News Regarding Electronic Instructions for Use for Medical Devices
Post date: 09/14/2011 - 1:12pm
On June 8, 2011, the European Commission released for comments the draft regulation on electronic instructions for use. The final deadline to submit comments was August 8, and the EU Regulatory...
-
India Medical Device Market Updates
Post date: 09/14/2011 - 1:07pm
The Indian medical device market is booming. It is currently worth about $3 billion and is expected to grow 12-16% during the next five years. Medical Devices Regulation Bill Though abolished in...
-
Choosing Clients Now That Will Add Value Later
Post date: 09/14/2011 - 1:01pm
It should be simple. Consultants have the expertise, and clients have the signed check. But not so fast. The enterprise-consultant relationship is much more complicated than the obvious transaction...
-
Parallel Path Development for Drug-Diagnostic Combinations
Post date: 05/19/2011 - 1:00pm
Personalized medicine is rapidly evolving in the industry and with regulatory bodies. Progress is evident on several fronts: drug and diagnostic corporate partnerships are emerging for co-development...
-
Effective Recall Notification and Public Awareness
Post date: 05/19/2011 - 12:56pm
One of the medical device industry’s biggest concerns when recalling a product from the market is to make certain that notification is provided in a timely and effective manner. The importance of a...
-
China May Implement Provincial Medical Tenders for IVDs
Post date: 05/19/2011 - 12:53pm
China may hold provincial-level tenders for high-end medical devices and IVD kits in 2011. Previously, China had conducted annual tenders for high-end medical devices on a national level, with the...
-
New Registration Requirements for Medical Devices in Poland
Post date: 05/19/2011 - 12:48pm
The new Polish act on medical devices that was published on September 18, 2010 (Official Journal of Law No. 107, Item 679) will officially go into full effect in May 2011 with the application of the...
