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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NPRA of Malaysia Issues Directive on Pre -Registration Test Results of Natural Products

On 12 May 2020. National Pharmaceutical Regulatory Division (NPRA) has issued a directive by the Director of Services Pharmacy pertaining …

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Malaysia Issues Directive for Physical Testing for Lot Release Activities for Vaccine and Plasma Products

On 12 May 2020,  the National Pharmaceutical Regulatory Division (NPRA) of Malaysia  has announced a directive by the Director of …

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Malaysia Issues New Guideline for Obsolete and Discontinued Medical Device

The Medical Device Authority (MDA) of Malaysia has recently issued a guidance document on 16 April 2020 for industry and …

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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. …

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New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia Coming into effect on the 1st of …

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Malaysia, Medical Devices advertising

As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from …

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Malaysia’s guideline for registration of combination products

Malaysia has fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products. …

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