The Medical Device Authority (MDA) of Malaysia has recently issued a guidance document on 16 April 2020 for industry and healthcare professionals.
The document provides a guideline to the relevant parties
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Field Safety Corrective Action (FSCA) launched by HSA Singapore
Effective from 6 April 2020, the Health Science Authority(HSA ) of Singapore has launched the new OSCAR system for Field Safety Corrective Action(FSCA).
Reporting and monitoring of FSCA have shifted from
read more...China NMPA Releases “Adverse Event Reporting Guidance for Medical Device Registrants”
On 03 April 2020, the NMPA of China has recently issued Guidelines for Medical Device Registrants to carry out adverse event monitoring on medical devices. The guidance was issued following
read more...Philippines issues New Circular on Registration of Human Influenza Vaccines
The Department of Health of the Philippines has recently issued Circular No: 2020-002 on 06 February 2020 pursuant to the Food, Drugs and Cosmetics Act.
The circular is intended to provide
read more...Chinese Pharmacopoeia 2020 draft approved by the Chinese Pharmacopoeia Commission
The Chinese Pharmacopoeia Commission has announced the Approval of Chinese Pharmacopoeia Version 2020 Draft during their 11th Executive Meeting.
The meeting which was held on 9th April 2020 introduced new and
read more...Pharmacovigilance Requirements Clarified by the FDA of the Philippines
The Department of Health of Republic of Philippines has issued a Circular No. 2020-003 effective on 26 February 2020 to provide clarification on the guidelines on pharmacovigilance obligations. The circular is
read more...Preannouncement of Name Change of AHWP to GHWP
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
read more...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
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