Regulatory Blog

Earlier today (27-October-2022) the Saudi Food & Drug Authority (SFDA) released updated guidance on "Good Regulatory Practice". A Good...

Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software,...

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued a Notification...

Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the...

USFDA's Center for Devices and Radiological Health released two updated, finalized guidelines yesterday and earlier today...

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...

Earlier today (30 September 2022) to ensure British people have timely access to medicines, the European Commission Decision Reliance...

Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health...

USFDA finalized and released Multiple Medical Devices Guideline earlier today (28 September 2022). 1. Guidance on: Clinical Performance...

A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...

This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...

On 13 September 2022, the Philippines FDA released updated guidelines on the Use of the Food and Drug Administration eServices Portal...

Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation...

Recently the MHRA updated its Medical devices: Software Applications (apps) guidance, which provides information on when software...

Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are...

On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...

The National Institute for Food and Drug Surveillance - Invima, informs manufacturers and importers of controlled technology medical...

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...

Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid...