Malaysia MDA Issues Guidelines for Application for Medical Device Advertisement Approval – Requirements
This guideline specifies the requirements for advertisement of medical devices that require approval and no approval required. The following materials …
Malaysia NPRA Strengthens Regulatory Control of Medicinal Gases Classified as Drugs
Malaysia NPRA issues Directive 8 of 2021 on Strengthening of the Implementation of Products Regulatory Control – Medical Gas Products …
Malaysia NPRA Issues Directive on Registration and Enforcement of Cell and Gene Therapy Products(CGTPs) in Stages
On 14 Dec 2020, Malaysia NPRA issues Directive 19 of 2020 on Registration And Enforcement Of Cell And Gene Therapy Products(CGTPS …
Malaysia MDA Launches New Version of Search System MEDICAL DEVICE AUTHORITY REGISTER for Registered Medical Devices and Licensed Establishments
On 4th November 2020, the Medical Device Authority of Malaysia issued an announcement to announce that the old PBPP Search …
Malaysia Updates Guideline for the Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption(CTX)
On August 2020, the NPRA of Malaysia has updated a document intended to guide the applicant in making Clinical Trial …
Malaysia Implements Evaluation of Bioequivalence (BE) Examination Requirements
On 2 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has agreed to the implementation evaluation of bioequivalence …
Malaysia Issues Document for GMP Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
On 01 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guidance document for good manufacturing practice(GMP) …
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 …
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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