Tag Archive for: ASEAN

Key Takeaways from VietNam’s CSDT Conference

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On June 28, 2024, The Vietnam Ministry of Health hosted a training session on how to prepare an ASEAN MDD Common Standard Technical Document.

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Expedited Market Access Now Available in Philippines

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On September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.

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PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

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New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

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THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

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With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)

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HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

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Hong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.

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ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

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Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.

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