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UK Medical Device Regulations: Registration and Export Guidelines
Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA)Â released updated guidance " Register medical devices to...
Sharan Murugan
Mar 133 min read
15 views
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FDA Philippines: Draft Guidelines for Registration of Chemical and Biological Pharmaceutical Products
The Food and Drug Administration (FDA) of the Philippines has recently published draft guidelines to streamline the registration process...
Sharan Murugan
Feb 222 min read
18 views
0 comments
SAHPRA South Africa: Renewal of the Certificate of Registration - Fee Schedule and Explanatory Notes
The South African Health Products Regulatory Authority (SAHPRA)Â has updated its " Fee Schedule and Explanatory Notes " Â to renew human...
Sharan Murugan
Feb 192 min read
13 views
0 comments
Navigating UK MHRA Guidance: Registration and Regulation of Medical Devices in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â oversees the regulation and registration of medical devices within the...
Sharan Murugan
Feb 182 min read
27 views
0 comments
EMA Guidance: EudraVigilance Registration Manual
Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...
Sharan Murugan
Jul 20, 20242 min read
30 views
0 comments
EMA Guidance: EudraVigilance Registration Documents
The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...
Sharan Murugan
May 18, 20242 min read
21 views
0 comments
Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for...
Sharan Murugan
Dec 19, 20231 min read
53 views
0 comments
UK MHRA: Guidance on Register Medical Devices to Place on the Market
Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...
Sharan Murugan
Dec 3, 20231 min read
20 views
0 comments
MHRA Guidance: Registration & Regulating Medical Devices in UK
Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...
Sharan Murugan
Apr 29, 20232 min read
64 views
0 comments
UK MHRA: Guidance on Register Medical Devices to place on the Market
Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...
Sharan Murugan
Mar 27, 20231 min read
111 views
0 comments
Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System
Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...
Sharan Murugan
Mar 11, 20231 min read
148 views
1 comment
Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device
Malaysia’s Ministrt of Healths Medical Device Authority (MDA) division recently prepared a guideline "Guidelines for implementation of...
Sharan Murugan
Jan 19, 20231 min read
41 views
0 comments
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
17 views
0 comments
SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products
Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and...
Sharan Murugan
Nov 19, 20221 min read
162 views
0 comments
EMA: Updated EudraVigilance Registration Manual
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...
Sharan Murugan
Aug 25, 20221 min read
40 views
0 comments
UK updated Guidance: Register Medical Devices to Place on the Market
Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...
Sharan Murugan
Jul 31, 20221 min read
16 views
0 comments
Ireland's guidance on New Application & Variations, Registartion Requirements,
Irelands HPRA released a few guidances in the past week Guide to New Applications and Variations to Manufacturer's Authorisations This...
Sharan Murugan
Feb 6, 20222 min read
22 views
0 comments
Regulating Medical Devices & Place on The Market – UK
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. This guide...
Sharan Murugan
Jan 7, 20221 min read
15 views
0 comments
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
Drug-Medical Device Combination Product (DMDCP): Primary mode of action is based on pharmacological, immunological or metabolic action...
Sharan Murugan
Nov 7, 20211 min read
12 views
0 comments
Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals
Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal The Drug Sector in Saudi Food &...
Sharan Murugan
Oct 19, 20211 min read
100 views
0 comments