Companies bringing a medical device to market in Egypt will need to familiarize themselves with recent changes being made by the Central Administration for Pharmaceutical Affairs (CAPA) to its regulatory standards. These alterations, which went into effect at the beginning of 2013, are designed to streamline the medical device approval process and make it easier … continue reading
Tag Archives: medical device manufacturing
European Medical Device Vigilance System Updated
In January 2013, new guidelines were issued by the European Commission that describe the European system for the notification and evaluation of Incidents and Field Safety Corrective Actions (FSCA) involving medical devices, known as the Medical Device Vigilance System. These guidelines cover the actions to be taken once the manufacturer or national competent authority receives information … continue reading
Medical Device Requirements Update: Russia Certification
The Russian medical regulatory agency Roszdravnadzor is urging medical device manufacturers planning to do business within the country’s borders to familiarize themselves with new product registration requirements. The updated regulations, which came into effect January 1, 2013, target both on-sale medical devices as well as those currently undergoing trials. Some medical device companies might not … continue reading
FDA 510k Submission – eCopy Program Final Guidance Published
The FDA 510k submission process now includes a final guidance for the eCopy Program. The document is titled “Final Guidance for Industry and FDA Staff – eCopy Program for Medical Device Submissions,” and it is available for download directly from FDA.gov. We initially covered the eCopy Program guidance when it was first issued in draft … continue reading
FDA Issues New eCopy Program Guidance
Medical device manufacturers are about to become familiar with a new digital FDA submission system. The eCopy Program is designed to provide the FDA with complete digital copies of almost each and every 510(k) regulatory submission, in addition to the paper submission that is still required to be presented with its signed cover letter. If … continue reading
Medical Device Excise Tax Update: Practical Implications for Device Companies
It has been over a year since we reported on the excise tax imposed on medical devices. In early June 2012, the U.S. House passed a bill to repeal the 2.3% tax on any sales of FDA-approved devices. However, now that the Supreme Court has upheld the Patient Protection & Affordable Care Act, the medical … continue reading
FDA Releases PMA Summary Memos For Medical Devices
A new pilot program associated with 2012′s push for greater transparency at the Center for Devices and Radiological Health (CDRH) has made public a database of Summary Review Memos for 180-Day PMA supplements relating to design changes for an approved medical device. What are Summary Review Memos? When a medical device manufacturer makes a significant … continue reading
FDA Makes Changes To Registration and Listing Requirements For Medical Devices
The FDA has made a number of changes to its requirements concerning the registration and listing of medical devices. The new requirements, which go into effect October 1, 2012, the start of the 2013 fiscal year, apply to both foreign and domestic establishments. Of the new requirements, the chief concern is the new requirement to … continue reading
Webinar – Reauthorization of MDUFA: How Will You Be Affected?
MDUFA, first enacted in 2003, is the legislation that allows the FDA to collect user fees from medical device manufacturers as part of the product submission and review process. This year, the legislation was reauthorized for the third time following successful negotiations between the Agency and industry. Aptiv Solutions, in collaboration with CHI-California Healthcare Institute … continue reading
Massachusetts Softens Stance On Physician Compensation From Medical Device Manufacturers
The Physician Payment Sunshine Act (PPSA), which we covered in a previous blog post, is focused on tracking payments, honorariums, and gifts made from pharmaceutical and medical device manufacturers to individual doctors over the course of the year, making any “transaction” of over $10 each or $100 annually part of the public record. The PPSA … continue reading
