Transcription of ASEAN MEDICAL DEVICE DIRECTIVE
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ASEAN MEDICAL DEVICE DIRECTIVE
ASEAN MEDICAL . DEVICE DIRECTIVE . one vision one identity one community ASEAN MEDICAL DEVICE DIRECTIVE The ASEAN Secretariat Jakarta The Association of Southeast Asian Nations ( ASEAN ) was established on 8 August 1967. The Member States of the Association are Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Viet Nam. The ASEAN Secretariat is based in Jakarta, Indonesia. For inquiries, contact: The ASEAN Secretariat Public Outreach and Civil Society Division 70A Jalan Sisingamangaraja Jakarta 12110.
device regulations, common technical documents and the progress made in implementation. HAVE AGREED as follows: ARTICLE 1 GENERAL PROVISIONS (1) Each Member State shall undertake all necessary measures to ensure that only medical devices which conform to the provisions of this ASEAN Agreement on Medical Device Directive (hereinafter referred to as
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