- Jan 31, 2020
Philippines Officially Launches New Medical Device Regulations
This issuance aims to provide information regarding the acceptance of applications based on AO 2018-0002, validity of issued Certificate...
- Dec 26, 2019
Philippines removes Embassy Authentication:Legalization vs Apostille eg Free Sale or Country of Orig
ARQon shared industry view in ASEAN meeting 5 years back on having recognition like Hague Apostille Convention, finally came true....
- Aug 29, 2019
Philippines: Medical Device Regulatory Updates
CDRRHR shared the following statistics: Manufacturers/Repacker: 74 Trader: 51 Distributors – Wholesalers, Importers, Exporters: 2,470...
- Mar 28, 2019
7th AMDC: ASEAN Borderline and Harmonized Classification documents released
The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...
- Dec 14, 2018
The Philippines registration phases of AMDD begins on 30 March 2019
The AO 2018-002 provides guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized...
- Dec 11, 2018
Key Endorsements in the 7th AMDC Meeting
The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...
- Aug 30, 2018
Toothbrush, sanitary napkins & baby diapers as medical devices? Philippines FDA reveals.
Philippines: On 6 June 2018, the Philippines FDA released Memorandum No. 2018-011, revealing the regulation criteria of the three...
- Aug 30, 2018
ASEAN - 25th meeting of the Pharmaceutical Product Working Group (PPWG)
ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...
- Aug 30, 2018
MEDTECH ASSOCIATIONS REGULATORY NETWORKING - Malaysia, Philippines, Thailand & Vietnam
ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device...
- Aug 30, 2018
Fees increase after years in Singapore HSA & Philippines FDA, and yearly approach increase by US
Singapore The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality,...