New User Fees Set for Foreign Medical Device Manufacturers in China

Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.

Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.

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“Tax Effect Not Minimal and is Responsible for 18,500 Job Losses”

The medical device tax has a “profound negative effect” on the nation’s jobs and innovation, AdvaMed President and CEO Stephen Ubl and Medical Imaging & Technology Alliance Executive Director Gail Rodriguez explain in an editorial.

The medical device tax has a “profound negative effect” on the nation’s jobs and innovation, AdvaMed President and CEO Stephen Ubl and Medical Imaging & Technology Alliance Executive Director Gail Rodriguez explain in an editorial.

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Roche and Qualcomm Collaborate to Innovate Remote Patient Monitoring

Many remote patient monitoring and management solutions today require patients to communicate results to their health care professionals in manual, time-consuming and non-digitized channels. Qualcomm Life and Roche hope to create an improved process for sharing health information between health care providers and their patients.

Many remote patient monitoring and management solutions today require patients to communicate results to their health care professionals in manual, time-consuming and non-digitized channels. Qualcomm Life and Roche hope to create an improved process for sharing health information between health care providers and their patients.

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Global Market for Refurbished Devices Will Reach $9.37 B by 2019

New market research report also notes that growth has been restricted by a lack of standardization of policies related to the reuse of medical devices and the hesitancy of some organizations to purchase refurbished medical equipment.

New market research report also notes that growth has been restricted by a lack of standardization of policies related to the reuse of medical devices and the hesitancy of some organizations to purchase refurbished medical equipment.

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Why is Biocompatibility Testing of Medical Devices Critical?

Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals. An upcoming series of seminars, organized by UL, will discu…

Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals. An upcoming series of seminars, organized by UL, will discu…

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How is Industry Dealing with Tax – Survey Results Tell Story

The U.S. Medical Device Excise Tax continues to draw scorn from industry advocates as a jobs killer. However, new data from a survey tells a different story about how executives are compensating for costs of the tax, and that story varies considerably by size of company.

The U.S. Medical Device Excise Tax continues to draw scorn from industry advocates as a jobs killer. However, new data from a survey tells a different story about how executives are compensating for costs of the tax, and that story varies considerably by size of company.

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FDA’s Single Audit Program Invites Participants

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

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