On 22nd November 2024, the Department of Health of the Republic of the Philippines issued Administrative Order No. 2024-0015 , aiming to...

On 19 August 2024, the Department of Health of the Philippines issued Administrative Order No.2024-0012, outlining the regulations for...

The Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26...

The Food and Drug Administration (FDA) of the Philippines released FDA Circular 2021-002-C on 29 March 2023 for the regulatory...

This issuance aims to provide information regarding the acceptance of applications based on AO 2018-0002, validity of issued Certificate...

ARQon shared industry view in ASEAN meeting 5 years back on having recognition like Hague Apostille Convention, finally came true....

CDRRHR shared the following statistics: Manufacturers/Repacker: 74 Trader: 51 Distributors – Wholesalers, Importers, Exporters: 2,470...

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...

The AO 2018-002 provides guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized...

The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...

Philippines: On 6 June 2018, the Philippines FDA released Memorandum No. 2018-011, revealing the regulation criteria of the three...

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...

ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device...

Singapore The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality,...

Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...

THE FIRST MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...

Meanwhile in Philippines, Food and Drug Administration Philippines (FDA) has come out with a Draft for New Schedule of Fees and Charges...