7th AMDC: ASEAN Borderline and Harmonized Classification documents released

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of Standards & Technical Requirements by ASEAN Medical Device Committee (AMDC):​

• List of Borderline medical device as of 10 Dec 2018

• List of Harmonized Medical Device Classification as of 10 Dec 2018

The above documents are in addition to the previous document endorsed at the 6th AMDC Meeting on 4 Apr 2018:

• Medical Device Guidance - Medical Device Mandatory Adverse Event Reporting

• Harmonisation Status of Medical Device Standard

• ACCSQ MDPWG Common Submission Dossier Template

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