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April 18, 2022

PHC’s drug injection device receives EU-MDR certification

The device allows patients to self-inject TNF inhibitors automatically without measurement or preparation.

PHC’s in vitro diagnostics division has received European Union Medical Devices Regulation (EU-MDR) certification for APP-1000, a motorized drug injection device.

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The class IIa portable medical device, is intended for delivering anti-inflammatory medications called tumour-necrosis factor (TNF) inhibitors.

It has been designed for providing precise, simple, and monitored drug injections at home for conditions that include rheumatoid arthritis.

Manufactured at PHC IVD’s Wakimachi plant in Japan, the drug injection device allows patients to self-inject TNF inhibitors automatically without measurement or preparation.

It comprises an LCD screen with illustrated guidance which makes it easier for patients to use.

The company stated that users can transfer the dosing history which is stored in the device memory to a smartphone through Bluetooth.

This allows patients and doctors to check the dosing record at any time remotely.

Additionally, patients will have the option to choose from three injection speeds depending on their need.

PHC IVD director and PHC Corporation board member Hiroyuki Tokunaga said: “We strive to provide best-in-class healthcare solutions that meet the needs of healthcare professionals and improve patients’ quality of life, by integrating precision manufacturing with digital technology.

“This EU-MDR certification will enable APP-1000 to be available to more patients and is an important milestone in our work to improve healthcare in the field of digital injectors.”

The receipt of EU-MDR certification allows the company to distribute the new motorized drug injection device in approximately 20 countries including Switzerland, South America and EU countries after June this year.

The EU-MDR regulation replaces the Medical Devices Directive and the Active Implantable Medical Devices Directive.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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