Search
UK MHRA: MD Guidance - Register Medical Devices to Place on the Market
Earlier today UK Medicines and Healthcare products Regulatory Agency released an updated guidance on "Register medical devices to place...
Sharan Murugan
Dec 6, 20221 min read
Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD
Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for...
Sharan Murugan
Nov 27, 20221 min read
Singapore HSA MedDev: Regulatory Guidelines for Laboratory Developed Tests (LDTs)
On 22nd November, 2022 Singapore's Health Sciences Authority released the final Regulatory Guidelines for Laboratory Developed Tests...
Sharan Murugan
Nov 27, 20221 min read
Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...
Sharan Murugan
Nov 27, 20221 min read
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According to the US Food and Drug Administration's draft guidance, the definition of a device has been updated according to the...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Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing...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
Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev
Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued a Notification...
Sharan Murugan
Oct 9, 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