Search
Irelands HPRA MD Guide: Performance Studies Conducted in Ireland
Irelands Health Products Regulatory Authority (HPRA) released (16- November-2022) guide on "Performance Studies Conducted in Ireland", to...
Sharan Murugan
Nov 16, 20221 min read
USFDA MD Guidance: Referencing “Device” and “Counterfeit Device”
According to the US Food and Drug Administration's draft guidance, the definition of a device has been updated according to the...
Sharan Murugan
Nov 12, 20222 min read
USFDA Guidance: Developing & Responding to Deficiencies - Least Burdensome Provisions
Earlier today (28-October-2022) the USFDA released final guidance on "Developing and Responding to Deficiencies in Accordance with the...
Sharan Murugan
Oct 27, 20221 min read
SFDA Guidance: Good Regulatory Practice & National Diagnostic Reference Levels
Earlier today (27-October-2022) the Saudi Food & Drug Authority (SFDA) released updated guidance on "Good Regulatory Practice". A Good...
Sharan Murugan
Oct 27, 20221 min read
USFDA MD Guidance: Breakthrough Devices Program - Reducing Disparities in Health & Health Care
Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing...
Sharan Murugan
Oct 23, 20221 min read
UK's MHRA Guidance: Software & AI as a Medical Device Change Programme
The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software,...
Sharan Murugan
Oct 17, 20221 min read
Philippines FDA: Guidelines on the Unified Licensing Requirements
Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the...
Sharan Murugan
Oct 9, 20222 min read
USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies
USFDA's Center for Devices and Radiological Health released two updated, finalized guidelines yesterday and earlier today...
Sharan Murugan
Oct 7, 20221 min read
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...
Sharan Murugan
Oct 6, 20221 min read
UK MHRA: European Commission Decision Reliance Procedure (EC DRP) Extension
Earlier today (30 September 2022) to ensure British people have timely access to medicines, the European Commission Decision Reliance...
Sharan Murugan
Sep 30, 20221 min read
USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests
Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health...
Sharan Murugan
Sep 30, 20221 min read
USFDA Guidance: Six Finalized Medical Devices Guidelines
USFDA finalized and released Multiple Medical Devices Guideline earlier today (28 September 2022). 1. Guidance on: Clinical Performance...
Sharan Murugan
Sep 28, 20222 min read
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...
Sharan Murugan
Sep 25, 20221 min read
USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
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...
Sharan Murugan
Sep 23, 20221 min read
Philippines FDA Guidance: License to Operate (LTO) Application of Retailers of Medical Devices
On 13 September 2022, the Philippines FDA released updated guidelines on the Use of the Food and Drug Administration eServices Portal...
Sharan Murugan
Sep 17, 20221 min read
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation...
Sharan Murugan
Sep 14, 20222 min read
UK MHRA's Guidance: Software Applications (apps)
Recently the MHRA updated its Medical devices: Software Applications (apps) guidance, which provides information on when software...
Sharan Murugan
Sep 7, 20221 min read
Malaysia’s MDA: HARMONISED CLASSIFICATION OFMEDICAL DEVICES IN ASEAN
Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are...
Sharan Murugan
Sep 7, 20221 min read
SwissMedic Guidance: On Export Certificates
On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...
Sharan Murugan
Sep 4, 20221 min read
Colombia INVIMA: Guidelines on the Application related to Sanitary Registries of Medical Devices
The National Institute for Food and Drug Surveillance - Invima, informs manufacturers and importers of controlled technology medical...
Sharan Murugan
Sep 2, 20221 min read