June 2021

philippines fda licensing medical device retailers

Philippines FDA Licensing of Medical Device Retailers

The Philippines FDA (Food and Drug Administration) has published a draft version of “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines”.  This draft is now open for comments from concerned parties until 24 July 2021. The draft guidelines specify those establishments that are required to obtain licenses to retail medical devices. …

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andaman medical at medtech integrates june 2021

Andaman Medical at Medtech Integrates Conference 2021

Andaman Medical is proud to be an Exhibitor Sponsor at this year’s Medtech Integrates Conference 2021 hosted by LifeScience Integrates. Victoria Caldy and Shouzheng Tan will be on hand to answer attendees’ queries on registering their medical devices and medical equipment in the Southeast Asian countries of Singapore, Malaysia, Indonesia, the Philippines, Thailand, and Vietnam.  …

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unique device identification singapore

Unique Device Identification Consultation in Singapore

A Unique Device Identification consultation is underway in Singapore. The Health Sciences Authority (HSA) has issued a draft document entitled “Guidance on the Medical Device Unique Device Identification (UDI) System” so that stakeholders can provide feedback on the document. The consultation is open now until 30 June 2021. Singapore does not currently have a standardized …

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meet thao andaman medical vietnam

Andaman Medical welcomes a third Regulatory Affairs Specialist in Vietnam

Help us in extending another  warm welcome to Dang Thi Phuong Thao  as part of our growing Andaman Medical team. Thao joins us as Regulatory Affairs Specialist and expert for the Vietnamese market in our office in Hanoi. She will be working alongside our Regulatory Affairs and Market Access team throughout Southeast Asia, assisting clients …

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Philippines FDA Class A Medical Device List Consultation

Philippines FDA Class A Medical Device List Consultation

The Philippines FDA has announced a virtual consultation on the draft Reference List of Class A Medical Devices and the draft addendum to the 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”. The PFDA has invited representatives …

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andaman medical new regulatory affairs specialist in vietnam

Andaman Medical welcomes a new Regulatory Affairs Specialist in Vietnam

Help us in extending a warm welcome to Nguyen Thi Nhat Le-Sunny as part of our growing Andaman Medical team. Sunny joins us as Regulatory Affairs Specialist and expert for the Vietnamese market in our office in Ho Chi Minh City. She will be working alongside our Regulatory Affairs and Market Access team throughout Southeast …

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andaman medical attends medtech canada regulatory conference 2021

Andaman Medical attends Medtech Canada Regulatory Conference 2021

Andaman Medical attends Medtech Canada Regulatory Conference 2021 where we’ll answer attendee’s queries on expanding their presence to the Southeast Asian countries of Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam.  As Canada is one of the Global Harmonization Task Force countries, medical devices that are manufactured and registered in Canada enjoy an advantage in …

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