Asian Harmonization Working Party in short (AHWP) will be changing its name to Global Harmonization Working Party (GHWP).
This change of name comes with a brand-new logo to provide better representation
Regulatory News
Australia publishes a new guideline and FAQ on exportation of therapeutic goods
Australia TGA has published information and a new FAQ on exporting therapeutic goods from Australia.
In order to export therapeutic goods from Australia for commercial purposes, certain regulatory requirements set out
Europe proposes to delay implementation of MDR due to COVID-19
The European Commission is working on a proposal to delay the implementation of the EU 2017/745 Medical Devices Regulation (MDR / the Regulation) until 2021.
This implementation which was due to
USA, FDA finalized their guidance on 510(k) third party review program (3P510k)
This guidance provides details on how types of devices are eligible for third party review and explain how third-party review organizations are being recognized.
The 38 paged guidance provides and explains
UK, MHRA updated guidance on medicines and medical devices
The MHRA are the authorities responsible for medical device regulations throughout the United Kingdom.
In March 2020, the MHRA updated its guidance on distinguishing medicines and medical devices focusing on cases
USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs)
USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs).
CGTs designation was created under FDA Reauthorization Act of 2017 (FDARA) with the purpose of
Singapore adds controls to certain mercury-added medical devices under EPMA
Singapore adds certain medical devices to the control list of Mercury-Added Products under the Environmental Protection and Management Act (“EPMA”).
From 1 January 2020 onwards, the manufacturing, import and export of
Singapore HSA released registration requirements on Next Generation Sequencing IVDs
Singapore, Health Sciences Authority (HSA) released the final document on Next Generation Sequencing NGS IVDs.
This document focuses on the requirements of NGS IVDs for registrations.
The scope covers both NGS based
Malaysia, guidance document for the pre-submission meeting.
Malaysia, guidance document for the pre-submission meeting.
On 13th February 2020, the Guidance Document for Pre-Submission Meeting (PSM) was unveiled.
PSM a new service provided by the Nationalized Regulatory Division of Pharmacy.