The Medical Device Authority (MDA) has released the Guidance Document, MDA/GD/0005, Second Edition, entitled “General Medical Device – Grouping” to assist the industry and healthcare professionals in achieving compliance with the Medical Device Act (Act 737) and its associated regulations. The guidance document has been updated to offer direction on
On March 7th, 2024, the Medical Device Authority (MDA) of Malaysia, issued Medical Device (Exemptions) Order 2024 where the Medical Device (Exemption) Order 2016 [P.U. (A) 103/2016] is revoked. The legislation covers the following: Exemption from Registration of Medical DevicesAny medical device is exempted from registration under section 5 of
To further develop the Philippines Food and Drug Administration’s (FDA) processes and automation of their system for initial, renewal and variation applications for the License to Operate (LTO) through the FDA eServices Portal System, the FDA proposed revisions on the documentary and other technical requirements for LTO applications to be
On February 19, 2024, the Medical Device Authority (MDA) of Malaysia released a draft guidance regarding the Placement of HIV Self-Test (HIVST) Kit in the Malaysian market.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
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