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New Adverse Event Requirements The SFDA also recently has issued new adverse event requirements for

New Adverse Event Requirements
The SFDA also recently has issued new adverse event requirements for medical devices. The “Tentative Guidance for the Monitory of Adverse Device Events” released on Sept. 16 last year briefly outlines the process for reporting and monitoring adverse events that medical device distributors, manufacturers and suppliers should follow.

The new adverse event requirements establish timeframes for adverse event reporting. Companies must notify the SFDA about mass medical device emergencies within 24 hours, suspicious deaths submitted within five working days, and serious injury that may lead to death within 15 days. Following the report, manufacturers must conduct an internal investigation and submit a report to the SFDA within 20 working days. All adverse event reports must include the SFDA’s “Medical Device Adverse Event Reporting Form.”

Also required are yearly summary reports of the previous year’s medical device adverse events. The deadline for submission of summary reports for the previous year is the end of January for manufacturers of Class II and III medical devices. Manufacturers must use the “Annual Summary Medical Device Adverse Event Reporting Form.” For Class I medical device manufacturers, annual reports do not need to be submitted to the SFDA, but they must have the reports in their records.

Manufacturers of all devices will be required to create central monitoring systems that include a product tracing system and formal archives for recording and monitoring adverse events. The company’s staff also must be trained in the correct procedure to monitor and report adverse events. Device manufacturers must establish internal standard operating procedures for mass medical device adverse event reporting, detecting, investigating and evaluating.

South Korean Firm Breaks Into U.S. Orthopedic Market

There’s been a lot of news lately about U.S. companies looking to international markets and regulatory approvals overseas to circumvent an increasingly unpredictable medical device approval process from the U.S. Food and Drug Administration (FDA) here at home.
But here’s a twist we don’t hear about as often—an orthopedic firm breaking into the highly competitive U.S. hip, knee and spine markets.

Corentec Co. Ltd., a Seoul, South Korea-based medical device company, is now based in America, offering its orthopedic products in the United States with the launch of its wholly owned subsidiary, Corentec America Inc. in Irvine, Calif. The announcement was made during the recent Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).
In addition to its implants, the company also plans to sell its line of instruments, used by orthopedic surgeons and neurosurgeons.

Michael Y. Son, vice president, Corentec America Inc., will lead the company’s sales and marketing efforts. At AAOS, Corentec highlighted its products already cleared for use in the United States. Products available immediately include a total hip and bipolar hip implants and a pedicle screw system. A total knee implant is awaiting FDA clearance, which the company expected to receive in the first quarter of this year. Additional products for hip, knee and spine currently are in the FDA clearance process and will be available later this year.
The company’s manufacturing currently is done in South Korea, where, according to company executives, the firm currently holds the leading market position for total hip arthroplasty in South Korea. During AAOS in 2011, the company’s founding surgeons presented a scientific paper that received the association’s Otto Aufranc Award, which is presented for “innovative research, either clinical or basic, encompassing important advances in the management of hip disorders.” Corentec’s paper focused on the company’s patented surface treatment technology, containing calcium and phosphate, the natural building blocks of bones, to enhance and maximize bone ingrowth.
“Our expansion into the U.S. market is yet another milestone for our company,” said Sung Taek Hong, CEO of Corentec Co. Ltd. “We have great expectations for Corentec America. “Through collaboration among a team of world-renowned orthopedic surgeons, academic leaders, scientists, and R&D engineers, Corentec has successfully developed a portfolio of hip and knee joint implants, spine implants and instruments that are recognized by the company’s customers for their high quality and reliability.”
According to company officials, the U.S. market is a “natural” fit for their global expansion plans.
“The U.S. market is dynamic and rapidly expanding as demand for orthopedic implants grows in relation to the aging population,” said Son. “Corentec is well-positioned to meet this growing demand by introducing a range of novel solutions for hip, knee, and spine in the coming decades. I see a great opportunity for Corentec America to make a significant mark … There are a number of attributes associated with our portfolio that differentiate our implants and instruments from our competitors.”
Corentec Co. Ltd. was founded in 2000.
—MPO Staff Report


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