Cambodia medical device regulations

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.