Department of Drugs and Food ASEANASEAN Agreement on Medical Device Directive
ASEAN Agreement on Medical Device Directive is the official DDF identifier for “ASEAN Agreement on Medical Device Directive”. ASEAN Agreement on Medical Device Directive is the official identifier DDF uses for this instrument.
- Instrument
- ASEAN
- Full name
- ASEAN Agreement on Medical Device Directive
- Category
- General
- Authority source
- English
- Readable HTML
- 24 articles · 1 language version
- Published
- September 2015
- Effective
- 1 January 2015
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
ASEAN Agreement on Medical Device Directive
The ASEAN Agreement on a Medical Device Directive, done at Bangkok, Thailand, on 21 November 2014 and in force from 1 January 2015 under Article 22. It is an ASEAN instrument, not a Cambodian national one, and is deposited with the Secretary-General of ASEAN (Article 24); Cambodia is a signatory and implements it through its Department of Drugs and Food, the authority named in the `agency` field. The Agreement carries its main text — recitals and Articles 1–24, covering the definition and scope of a medical device, essential principles of safety and performance, the four-class risk classification, conformity assessment, registration and placement on the market, the person responsible for placing a device on a member-state market, technical documents, reference to technical standards, labelling, medical device claims, the post-marketing alert system, clinical investigation, institutional arrangements, safeguard clauses, confidentiality, special cases, implementation, amendment, dispute settlement, reservations, entry into force, annexes and the depositary — together with its eight annexes: Annex 1 essential principles, Annex 2 risk-classification rules for non-IVD devices, Annex 3 risk-classification rules for IVD devices, Annex 4 the ASEAN Common Submission Dossier Template, Annex 5 post-marketing alert system requirements, Annex 6 the components of a Declaration of Conformity, Annex 7 labelling requirements, and Annex 8 clinical investigation. Ingested from the ASEAN Secretariat's published PDF (106 pages) as one expression under rule 4, with the publication's own front matter excluded as publisher furniture.
ASEAN Agreement on Medical Device Directive is the official identifier DDF uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.