Malaysia Issues Guidance Documents on Complaint Handling and Mandatory Problem Reporting for Medical Devices
In line with the objective to assist the healthcare professionals in the industry towards compliance with the Medical Device Act …
New advertising guideline by Japan for IVD Marketing Information
On 01 April 2019, the Japan Association of Clinical Reagents Industries (JACRI) issued a guideline for marketing information on In-Vitro …
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 …
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 …
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 …
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 …
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 …
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 …
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”). …