China Publishes Policy paper on Five-Year Plan to Strengthen Adverse Event Monitoring System

Effective from 30 July 2020 onward, the National Medical Products Administration(NMPA) of China released a policy paper on its five-year …

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Hong Kong Continues Trial Scheme for Expedited Approval of Class II/III/IV Medical Devices

The Medical Device Division (MDD) will continue the trial scheme to streamline the application and approval process of Class II/III/IV …

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Taiwan Issues Guidance on In-Vitro Companion Diagnostic Devices (CDx)

The Taiwan FDA issues on 16 July 2020 the guidance on in-vitro companion diagnostic devices (CDx), which are aimed to …

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China Issues Specifications of Creating Periodic Risk Assessment Report for Medical Devices

The National Medical Product Administration (NPRA of China) has published specifications for creating a Periodic Assessment Report for Medical Devices(NO. …

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Malaysia Publishes Guidance Document for Medical Device Distribution Records

On June 2020, Medical Device Authority (MDA) of Malaysia has published a guidance document to set a framework for the …

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China Publishes Guidance for Medical Device Good Manufacturing Practice On-Site Inspections on Standalone Software

On 29 May 2020, the National Medical Products Administration ( NMPA) of China has formulated a  “Guiding Principles for On-site …

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Malaysia Issues Circular on Transition Period for Medical Device Advertisement

On 20 May 2020,  the Medical Device Authority (MDA) of Malaysia has issued a circular pertaining to the transition period …

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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 …

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NMPA of China Releases Evaluation Guideline for Raw Material Changes in Passive Medical Devices

On 19 May 2020, the National Medical Products Administration(NMPA) of China has formulated a document to evaluate the changes in …

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