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Indonesia Halal Certification 2021 – new regulations

The implications of the halal certification process for medical devices incorporating animal products in Indonesia Catering to Indonesia’s growing need for halal products Indonesia accounts for the largest Muslim population worldwide. With approximately 225 million Muslims, there is an increasing demand for Halal products. In response to this growing need,

Covid 19 test kits Philippines

The Philippines FDA sets new performance requirements for COVID-19 test kits

The Philippines FDA has set new performance requirements for the various types of COVID-19 test kits available on the market in the Philippines with immediate effect. The PFDA issued Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection” on 23rd March 2021 which applies

Thai FDA issues new regulations on medical device classification and registration

Thai FDA issues new regulations on medical device classification and registration

The Thai FDA has issued new regulations for medical device classification and registration part of which came into effect on 15th February 2021 and the remainder comes into effect on 17th March 2021. The new regulations include changes in product classification for both IVD and non-IVD medical devices, types and stages of submission,

Upcoming changes to medical device registration in Thailand

Upcoming changes to medical device registrations in Thailand

All medical devices to enter Thailand, whether manufactured domestically or imported, are regulated by the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health. Currently, the registration of medical devices is classified according to the level of control, which lists 3 levels: Licensed Medical Devices Notified Medical

Philippines FDA issues implementation schedule of AO 2018-002

Philippines FDA issues implementation schedule of AO 2018-002

The Philippines FDA issued Circular no. 2021-002 on Monday 4th January 2021, which contains the implementation scheduleof the Administrative Order No 2018-002: “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” over three (3) phases. Administrative Order (AO) no. 2018-002 section IX stipulates that the requirement

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