Swiss Single Registration Number (CHRN)
This Article deals with the New Registration Policy of the Swiss Agency, published on May 22, 2022 by Swiss Medic. Medical Device Manufacturers are now needing additional consultants to assist them with the CHRN. Swissmedic, the Swiss Agency for Therapeutic […]
Read MoreRegulation of all Licensed Class A and B Medical Devices by October 2022
This article released on 30th September 2022 talks about the importation of Class A and B Medical Devices according to a notification issued by the Ministry of Health & Family Welfare (MoHFW) on February 11, 2020. It has been released […]
Read MoreMedical Device Makers are Told to get license by Oct 1, 2022 for Hassle Free Import
This article deals with the new rules of the Tamil Nadu Government that Medical Device Makers should get the import license on or before October 1 or else action will be taken. The Tamilnadu State Drug Control Director, Vijayalakshmi said […]
Read MoreReclassification of Active Implantable Medical Devices by the TGA
This Article Deals with the Reclassification of Active Implantable Medical Devices. The Australian Department of Health Released a Guidance on the transitional arrangements and obligations which was Published in July 2022. Active implantable medical device or AIMD means an active […]
Read MoremRNA Vaccines Induce Faster Antibody Response Against Infectious Diseases
This Article deals with the mRNA Vaccines and its Antibody Response against the Diseases published on August 2, 2022. The study, published in the journal, describes that mRNA vaccines induce an antigen-specific antibody response within a very short period after […]
Read MoreMonkeypox Virus Outbreak is a Global Health Emergency
This Article Deals with the Monkeypox Outbreak and its spread across the world. The World Health Organization Declared this as a Public health Emergency in the International Health Regulations Emergency Committee Meeting (EC) on July 23, 2022. Monkeypox presents “a […]
Read MoreNew Rules for Unique Device Identification System, NMPA
This Article deals with the New Rules for Unique Device Identification System. The Chinese NMPA has Released a New Article talking about the UDI System for the Territory of the People’s Republic of China which was published on June 30, […]
Read MoreIncreasing Importation of Medical Devices affecting SME’s
This news article deals with the increasing demand for Imported Medical Devices and Products into India. In India, the Medical Device Industry Importation has surged by 41% this year leading to the shut down of several local indian companies. The […]
Read MoreNew Draft Regulations for IVD’s in India
This news article deals with the updates in the IVD regulations in India. They have come up with three drafts as follows – Draft Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – The CDSCO has issued an […]
Read MoreUnique Device Identification Rules, SFDA
The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s Medical Device Regulator has pushed the enforcement of the Unique Device Identification by a year in phases. The SFDA bought in these regulations on 1st October, 2020. The new dates are […]
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