Philippines | Rules and Regulations Governing the Issuance of an Authorization for an In-Vitro Diagnostic (IVD) Medical Device Based on the ASEAN Harmonized Technical Requirements
Title of document
Draft Administrative Order No. ___ : Rules and Regulations Governing the Issuance of an Authorization for an In-Vitro Diagnostic (IVD) Medical Device Based on the ASEAN Harmonized Technical Requirements (12 page(s), in English)
Republic Act No. 9711, otherwise known as the "Food and Drug Administration Act of 2009", and its Implementing Rules and Regulations, declare that it is the policy of the state to insure the safety, efficacy and quality of IVD medical devices in the country so as to protect the health of the Filipino people.
Notifying member: Philippines
Protection of human health or safety
This Administrative Order aims to specify the rules, guidelines, procedures and requirements of the FDA-CDRRHR relative to the issuance of an authorizations for IVD medical devices adapting the provisions of ASEAN AMDD.
Department of Health - Food and Drug Administration
- Submission: 02/04/2019
- Reception: 02/04/2019
- Distribution: 03/04/2019
- Final date for comments: 02/06/2019
- Proposed date of adoption: N/A