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ARQon
May 8, 20241 min read
Hong Kong: MDD Introduces a One-Stop e-Service, Medical Device Information System (MDIS)
Medical Device Division (MDD) of Hong Kong introduced a new one-stop e-service platform for online application submissions for medical...
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ARQon
May 7, 20241 min read
Brazil: ANVISA Announces to Extend B-GMP Certificates for MDSAP-Certified Medical Device Manufacturers (w.e.f 1 April 2024)
On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing...
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ARQon
May 2, 20241 min read
Philippines: South Korean MFDS as Reference Drug Regulatory Authority
On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory...
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ARQon
Apr 23, 20241 min read
Philippines: Regulatory Flexibility Extension for the Unlisted Class B, C, and D Medical Devices in the Registrable Medical Devices List
The Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26...
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ARQon
May 3, 20232 min read
Philippines: Regulatory Flexibility Guidelines for Unlisted Registrable Medical Devices
The Food and Drug Administration (FDA) of the Philippines released FDA Circular 2021-002-C on 29 March 2023 for the regulatory...
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