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Finland adopts New Act on Clinical Trials Legislation (FIMEA)
The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the...
Sharan Murugan
Nov 7, 20211 min read
UK-MHRA Guidance on Pharmacovigilance Procedures
This guidance summarises UK-MHRA’s approach to pharmacovigilance. The Guidance on pharmacovigilance procedures was Updated on 14 October...
Sharan Murugan
Oct 19, 20211 min read
Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices
On 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and...
Sharan Murugan
Oct 13, 20211 min read
European Commission’s MCGD New Guidance on Classification of Medical Devices
European Commission’s Medical Devices Coordinating Group (MDCG) on 04-October-2021 issued guidance to support manufacturers classify...
Sharan Murugan
Oct 8, 20211 min read
USFDA’s drafts “Investigator Responsibilities–Safety Reporting for Investigational Drugs & Devices
The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting...
Sharan Murugan
Oct 3, 20211 min read
MHRA Guidance on need to Review Registration of Medical Devices
MHRA agency on 27 September 2021, provided the advice in an update to its guidance on "registering medical devices. MHRA has asked...
Sharan Murugan
Oct 3, 20211 min read
USFDA’s Electronic Submission Template for Medical Device 510(k) Submissions
On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket...
Sharan Murugan
Sep 29, 20211 min read
India CDSCO -Guide for Manufacturers/Importers for Registration of Non-Notified Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...
Sharan Murugan
Sep 29, 20211 min read
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...
Sharan Murugan
Sep 29, 20212 min read
South Africa- Updated Guideline on Classification of Med.Dev and IVDs & Medicines for use in PHU
Updated Guideline on Classification Of Medical Devices and IVDs The aim of this guideline is to assist manufacturers, importers,...
Sharan Murugan
Sep 17, 20211 min read
UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
Managing clinical trials during Coronavirus (COVID-19) On 8th September 2021, MHRA updated the guidance on How investigators and sponsors...
Sharan Murugan
Sep 11, 20211 min read
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...
Sharan Murugan
Aug 30, 20211 min read
MDCG Guidance for NBs, importers, & distributors: QMS certification for relabelling & repackaging
The MDCG Guidance provides an overview of activities, requirements, auditing, surveillance and changes and minimum content of the...
Sharan Murugan
Aug 25, 20211 min read
FDA Export Certification - Revised Guidance -US FDA
This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments. This...
Sharan Murugan
Aug 21, 20211 min read
Regulation & Re-classification of Software based Medical Devices - TGA Australia
Software-based Medical Devices are medical devices that incorporate or are software, including software as a medical device, or software...
Sharan Murugan
Aug 19, 20211 min read
Guidance on Issuing of an Authorization for Med Device based on ASEAN Requirements - PhilippinesFDA
The Philippine Food and Drug Administration (FDA) released an addendum to circular (to FDA Circular No. 2021-002) on the transition to...
Sharan Murugan
Aug 19, 20211 min read
FY2022 User Fee Table -USFDA
The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...
Sharan Murugan
Aug 13, 20212 min read
MDCG Guidance on UDI Integration -European Comission
Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...
Sharan Murugan
Aug 6, 20211 min read
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...
Sharan Murugan
Jul 29, 20211 min read
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...
Sharan Murugan
Jul 28, 20211 min read