Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Singapore Revises Policy On Permission to Supply Devices Undergoing Corrective Action

This article was originally published in Clinica

Executive Summary

Singapore's Health Sciences Authority has adopted a revised policy, effective April 18, under which it will apply a new risk-based approach to decide whether or not to allow medical device companies to continue supplying products affected by a field safety corrective action (FSCA) when the corrective action is still in progress.

You may also be interested in...



EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Global Pharma Guidance Tracker – March 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

EU Regulators Explain How To Ensure Transitioned Trials Align With CTR

Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT103341

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel