TGA Australia New Powers can help decrease patients exposure to medicine shortages.
The Australian Registry of Therapeutic Goods (ARTG) has made measures to help patients deal with the consequences of medication shortages, including the temporary import or supply of an internationally licensed pharmaceutical in place of one that is in limited supply. […]
Read MoreFDA Risk Classification on toxic compound exposure while using dialysis devices
This article deals with the FDA risk classification continued evaluation of the potential risk of hazardous chemical exposure when utilizing dialysis devices. The FDA has issued a letter to health care providers to assess the risk of exposure to non-dioxin-like […]
Read MoreNMPA 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, the Notice of the General […]
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 medical device intended for human […]
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 to track the functionality of […]
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 Act (Act 737) and its […]
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 occurrences of squamous cell carcinoma […]
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 expands the attack surface for […]
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 flaws, restrictions, and limitations that […]
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 and surgical instruments. Extra medical […]
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