Registrable Medical Devices

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Frequently Asked Questions About Medical Devices | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices

This document supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, and Emergency Use of Unapproved Medical Devices (September 1998) Office of...

FDA Circular No.2021-017 || Reference List of Class A …

https://www.fda.gov.ph/fda-circular-no-2021-017-reference-list-of-class-a-medical-devices/

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 the ASEAN …

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution of …

FDA Circular No.2021-002-A - Food and Drug …

https://www.fda.gov.ph/fda-circular-no-2021-002-b-addendum-to-fda-circular-no-2021-002-re-full-implementation-of-administrative-order-no-2018-0002-entitled-guidelines-governing-the-issuance-of-an-authorizatio/

On 4 January 2021, FDA Circular (FC) No. 2021-002 was issued for the full implementation of Administrative Order (AO) No. 2018-0002 entitled “Guidelines Governing the Issuance …

Medical Device Registration and Approval in the Philippines

https://arazygroup.com/medical-device-registration-philippines/

Certain registrable IVD devices such as pregnancy test kits using urine specimen, HIV testing kit, COVID-19 test kits and reagents are also subject to a local …

Guidelines published for transition in Philippines to ASEAN …

https://www.emergobyul.com/news/guidelines-released-transition-philippines-asean-harmonized-requirements

Creating a harmonized medical device regulatory framework has been a priority of ASEAN since the early part of last decade, and 2014 yielded the official signing …

Philippines FDA: List of registrable IVDs - Andaman Medical

https://andamanmed.com/philippines-fda-list-registrable-ivds-draft-guidelines-comments/

The Philippines Food and Drug Administration (FDA) is seeking comments from IVD manufacturers and distributors (importers/exporters/wholesalers) on draft …

Medical Devices - Food and Drug Administration

https://verification.fda.gov.ph/medical_deviceslist.php

Feb 14, 2023

Medical Devices – Asia Regulatory Updates round up

https://www.makrocare.com/blog/medical-devices-asia-regulatory-updates-round-up-aug-2021/

ambulatory ventilators including continuous positive airway pressure (CPAP) devices; and bi-level positive airway pressure (BiPAP) devices. 11. Regulation of …

HSA | Registration guides

https://www.hsa.gov.sg/medical-devices/registration/guides

Medical device registration Registration guides Once you have determined the evaluation route and risk class of your medical device, use the relevant guide to find out the …

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