On February 19, 2024, the Medical Device Authority (MDA) of Malaysia released a draft guidance regarding the Placement of HIV Self-Test (HIVST) Kit in the Malaysian market. This guidance, identified as MDA/GD/0065, aims to provide direction for businesses interested in importing, exporting, or placing the Human Immunodeficiency Virus Self-Test kit
During the harmonization to ASEAN requirements, PFDA aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all Class B, C, and D medical
On 30 December 2023, the Authority of Vietnam issued Decree 96/2023/NĐ-CP detailing several articles of the Law on Medical Examination and Treatment. Furthermore, Article 147 of this Decree has amended and supplemented some articles of Decree 98/2021/NĐ-CP regarding “Medical Device Management.” The highlighted amendments and supplementations to the articles of
The Medical Device Authority (MDA) has released Guidance Document MDA/GD/0067, First Edition, titled “Post Market Information Exchange for ASEAN Member States“, to assist the industry and healthcare professionals in complying with the Medical Device Act (Act 737) and its associated regulations. The development of the Guideline on Medical Device Post
The Medical Device Authority (MDA) of Malaysia has released Guidance Document MDA/GD/0066, First Edition, titled “Importation of Medical Device for Personal Use”, to support the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its associated regulations. This guidance serves as a
On 24th January 2024, the Health Sciences Authority (HSA) of Singapore issued Revision 10 of the “GN-15 Guidance on Medical Device Product Registration”. The highlighted key update, especially for the evaluation routes of Immediate Class B Registration (IBR condition 1) and Expedited Class C Registration (ECR-1), is as follows: Removal of
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