NMPA certifies third batch of medical equipment
This article discusses NMPA Certification the decision to implement unique identification of medical devices for some Class II medical devices in order to continue implementing the Regulations on the Supervision and Administration of Medical Devices, […]
Read MoreBans on Medical Devices by FDA Medical Device Regulations
Bans on Medical Devices by FDA A medical device ban is a complete restriction on all present and future production, distribution, and sales of medical devices if the FDA Medical Device Regulations believes that a […]
Read MoreHow to Report Medical Device Issues by FDA
This article deals with mandatory reporters like manufacturers, importers, device user facilities and voluntary reporters who each submit medical device 510k reporting to the FDA. Medical device reports are a post market monitoring method used […]
Read MoreRegistration Requirements for Medical Gas System by MDA
This article deals with the Medical Gas System Guidance Document. The Medical Device Authority (MDA) created this Guidance Document to support the industry and healthcare professionals in their efforts to comply with the Medical Device […]
Read MoreReports of SCC in the Capsule Around Breast Implants
This article deals with the reports of squamous cell carcinoma in the capsule around breast implants released by the U.S. Food and Drug Administration (FDA) on March 8, 2023. The Food and Drug Administration stated that […]
Read MorePublic Consultation on a Medical Device Cybersecurity Labeling System
This article deals with the public consultation for the cybersecurity labeling scheme for medical devices. Medical equipment is increasingly being linked to hospital and home networks in order to improve patient care. However, this connectivity […]
Read MoreVietnam Medical Device Registration to Address the Medical Supply
This Article deals with the new Decree Released by the Vietnam Medical Device Registration on March 4, 2023. The Deputy Prime Minister Tran Hong Ha signed Decree No. 07/2023/ND-CP. This amendment’s goal is to correct […]
Read MoreConditions of Emergency (Medical Devices) : FDA Registration
This article is about public health emergencies when a medical device is used to manage or prevent an emergency. These consist of diagnostic testing equipment and materials, personal protective equipment such as gloves or masks […]
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