The Medical Devices Authority (MDA) has joined Operation Pangea XV from June 22 to July 05, 2022, which is a worldwide campaign operation to carry out large-scale enforcement actions against the sale of counterfeit and illicit medicines and medical products. This operation is coordinated by the International Criminal Police Organization
With the emergence of COVID-19 pandemic, the Ministry of Health is continuing its effort to control the epidemic by adjusting its regulations. On August 1, 2022, the Ministry of Health has issued Circular No. 06/2022/TT-BYT defining the list and issuance of registration numbers of medical devices intended for COVID-19 pandemic
On August 1, 2022, the Vietnamese Ministry of Health issued Circular 05/2022/TT-BYT, regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices. This circular contains the following details: A. Supplement the list of in vitro diagnostic medical device that is not subject to quality
Indonesia’s government through the Ministry of Health continues to support the usage of locally manufactured medical devices, especially the ones purchased via e-Catalogue by national hospitals. This campaign is stated under Instruction President No. 2-year 2022, which instructs the Ministry of Health to update the policies in accelerating and increasing
On July 14th 2022, the MDA announced Medical Device Centralized Reporting System (Medcrest) is ready to be used by an establishment of a medical device. All Mandatory Problem Reporting, Field Corrective Action and Device Recall can be done online using the Medcrest system starting July 15th, 2022. This new system
Health Sciences Authority (HSA) Singapore has published a new guidance document ‘Regulatory Guidelines for Laboratory Developed Test (LDTs)’ which is opened for public consultation with industry stakeholders, from 12 Jul 2022. LDTs are considered in vitro diagnostic tests (IVDs) as defined in Health Product (Medical Device) (HP(MD)) Regulations. The scope
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
