A guideline paper titled MDCG 2022-20 - Substantial Modification of Performance Study under the In Vitro Diagnostic Medical Devices...

1. Change Application as New Compliance-to-Maintain Requirement The National Medical Products Administration of China (NMPA) published an...

A trade association for the pharmaceutical industry and a number of pharmaceutical companies urged the US Food and Drug Administration...

Thailand Food and Drug Administration (FDA) published guidelines to determine the state and risk categorization of medical device...

An efficient initiative had been launched on February 2022 by Indonesian government on simplifying the process of products getting listed...

Medical Device Authority of Malaysia (MDA) has announced the amendment of requirement establishment license renewal on 13 December 2022...

On December 9, 2022, the U.S. Food & Drug Administration (FDA) released a fresh draft of its HFE guideline manual, entitled Content of...

In this article, we bring you the key aspects of the Modernization of Cosmetics Regulation Act or MOCRA which independent and small...

The Guidance on Clinical Evidence Requirements for Medical Devices has been finalized by Health Canada. The general guidelines and...

New regulations for the oversight and management of businesses implementing medical device safety, as well as proposed rules for the...

GOVERNMENT AUTHORITY (CDSCO) The Central Drugs Standard Control Organization (CDSCO), a division of the Directorate General of Health...

Importers for Voluntary The Ministry of Health and Family Welfare published the Medical Device Rules on February 11th, 2020, as an...

In order for the user to get technical support, the fifth version of the MDA/GD/0026 places a strong emphasis on the necessity for a...

The Thai FDA implemented a new submission procedure that will give an initial review of the provided documents and a response within 15...

LISTED DEVICES TO BE GIVEN TENDER PREFERENCE BY DEPARTMENT OF HEALTH The Hong Kong Department of Health (DH) announced the launch of a...

Food and Drug Administration (FDA) Circular No. 2022-004, published by the FDA in June 2022, offers information on the facilitated...

Food and Drug Administration (FDA) Circular No. 2022-005, which offers some details on the procedure for labeling drug items under...

A draft of the Regulatory Guidelines for Laboratory Developed Tests (LDTs) has been made available by the Medical Devices Cluster (MDC)...

On August 1st, 2022, the Health Sciences Authority (HSA) will introduce the Voluntary Notification System (VNS) for Traditional Medicines...

Singapore wants to broaden the scope of its cybersecurity labeling program to cover medical devices, particularly those that handle...