Draft for Comments of Banning of all Mercury-Containing Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes
All comments can be sent at [email protected] . Deadline of submission of comments shall be by 14 August 2021. I. BACKGROUND The government signed the Instrument of Ratification of the […]
Draft for Comments of Adoption of the Post Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD)
All comments can be sent at [email protected] Deadline of submission of comments shall be by 07 August 2021 I. BACKGROUND / RATIONALE Republic Act No. 3720, otherwise known as the […]
Draft for Comments of Guidelines on the Licensing of Retailers of Medical Devices in the Philippines
All comments can be sent at [email protected] with copy furnished to [email protected] . Deadline of submission of comments shall be by 24 July 2021. I. RATIONALE Republic Act No. 9711, […]
Revised Bureau Circular No. 2007-010 entitled Guidelines in the Initial Issuance and Renewal of License to Operate for Iron Rice Premix Manufacturer / Repacker / Importer and Updating of the Standards for Iron Rice Premix
OBJECTIVES: This Circular aims to provide updated guidelines and standards on the suitable level of iron in rice in the manufacture of iron-rice premix to help address iron deficiency anemia […]
Draft for Comments of Revised Post-marketing Surveillance Requirements for New Drugs under Monitored Release
All comments can be sent at [email protected] Deadline of submission of comments shall be by 24 May 2021. I. BACKGROUND On 15 March 1989, Department of Health Administrative Order (AO) […]
Draft for Comments of Interim Guidelines on the Renewal of Current Good Manufacturing Practice (cGMP) Clearance of Foreign Drug Manufacturers
All comments can be sent at [email protected] Deadline of submission of comments shall be by 17 May 2021. I. RATIONALE/BACKGROUND Pursuant to Administrative Order (AO) No. 2013-0022, entitled, “Guidelines for […]
Draft for Comments of Implementing Guidelines for Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Drug Products and Vaccines
All comments can be sent at [email protected] Deadline of submission of comments shall be by 04 May 2021. I. RATIONALE Republic Act No. 3720, otherwise known as the “Foods, Drugs […]
Draft for Comments of List of Class A Medical Devices
I. BACKGROUND AND RATIONALE On 26 January 2018, DOH Administrative Order (AO) No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on […]
Draft for Comments of Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”
All comments can be sent at [email protected] Deadline of submission of comments shall be by 14 May 2021. I.BACKGROUND/RATIONALE On 4 January 2021, FDA Circular (FC) No. 2021-002 was […]
Draft for Comments of Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/Systems
I. BACKGROUND Streamlining of License to Operate (LTO) application procedures is one of the key web infrastructures that the Food and Drug Administration (FDA) is undertaking. This is in […]