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.
the medical device is intended according to the specifications of its product owner as stated on any or all of the following: (i) the label of the medical device; (ii) the instructions for use of the medical device; (iii)the promotional materials in relation to the medical device. (j)in vitro “ diagnostic (IVD) medical device” means any
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