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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...
ARQon
May 8, 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...
ARQon
May 7, 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...
ARQon
May 2, 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...
ARQon
Apr 23, 20241 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...
ARQon
May 3, 20232 min read
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