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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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