홈

규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

#medical devices ×

UPDATED
규제 업데이트
2026년 9월 25일•1분 읽기
Canada Recalls PERMA-HAND Silk Suture for Unapproved Tubing Fluid
Health Canada has recalled Ethicon's PERMA-HAND™ Silk Suture after discovering an unapproved alcohol‑based tubing fluid in its primary packaging.
UPDATED
규제 업데이트
2026년 9월 25일•1분 읽기
Health Canada Recall: PERMA‑HAND™ Silk Suture Contaminated with Alcohol‑Based Tubing Fluid
Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Stryker alerts premature battery drain in certain devices
Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Stryker devices may experience premature battery drain, affecting operation
Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Medtronic Reports 15 Complaints on Incompatible Component Health Canada
Medtronic logged 15 complaints about incompatible leads or extensions causing surgical delays, but found no performance issues.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Medtronic Reports 15 Complaints Over Incompatible Component Selection
Medtronic logged 15 complaints from Jan 2020 to Aug 2026 involving incompatible leads or extensions, causing surgery delays or replacements, but found no device performance issues.
UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
Cook Medical Alerts: Female Luer Lock Adapter May Be Misaligned in Certain Device Lots
Cook Medical reports that certain device lots may have a misaligned female luer lock adapter due to manufacturing errors.
UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
Cook Medical alerts on potential manufacturing defect in cystoscopic injection needle
Cook Medical reports that certain cystoscopic injection needle lots may have a misaligned female luer lock adapter.
UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
Health Canada Issues Alert on 3930M Transvenous DF4 Cardiac Lead Adhesive Issue
Health Canada alerts that the 3930M transvenous DF4 cardiac lead may suffer driveshaft separation due to insufficient adhesive bonding, potentially leading to lead fracture.
UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
MHRA Field Safety Notices Issued 14‑18 September 2026
MHRA published a series of field safety notices between 14‑18 Sep 2026 covering cardiac occluders, circulatory assist catheters, orthopedic instruments, endoscopic needles, imaging systems and diagnostic software.
UPDATED
규제 업데이트
2026년 9월 21일•1분 읽기
South Korea Expands Insurance Support for Insulin Pumps and CGMs to Severe Type 2 Diabetes
The Ministry of Health and Welfare will extend coverage of insulin pumps and continuous glucose monitors to severe type 2 diabetes patients with pancreatic dysfunction starting December.
UPDATED
규제 업데이트
2026년 9월 18일•1분 읽기
Health Canada Warns of Counterfeit Soprano Laser Hair Removal Devices
Health Canada alerts that counterfeit Soprano laser hair removal machines, made by Beijing Perfectlaser, are being sold to Canadian clinics, posing health risks.