The purchase of self-test kits for COVID-19 requires providing personal information at sales premises authorized by MDA and KPDNHEP, and the collection of this information is a growing concern among buyers. MDA is aware of the concerns among users and would like to clarify that the requirement to record this
Singapore’s Health Sciences Authority published new updates to the guidance document titled ‘Guidance on Special Access Route (SAR) Rev 2’. The announcement is part of HSA’s effort to strengthen regulatory oversight on the importation and local use of unregistered high-risk medical devices requested by qualified practitioners or public healthcare facilities.
Singapore is the first WHO member state to achieve the status of Maturity Level (ML) 4, the highest level of attainment for a regulatory system classification, for its advanced medicines regulatory system. The Health Sciences Authority (HSA) is the first National Regulatory Authority (NRA). International assessors and WHO officials reviewed
Malaysia’s Ministry of Health’s Medical Device Authority (MDA) released a draft amendment or second edition of Medical Device Guidance (MDG) for Personal Protective Equipment (PPE) requirements. The amendment is to the September 2021 first addition MDA/GD/00558. The draft document provides guidance to healthcare facilities and establishments. Specifically, those that deal
The announcement was made on March 7, 2022, by the Medical Device Control Division of the Food and Drug Administration Ministry of Public Health (MOPH) of Thailand. Submit an application through E-submission if you are a medical device registrant wishing to check the risk classification and grouping. Expect to pay
The Philippines FDA issued an amendment to Circular no. 2021-002-A entitled “Addendum to FDA Circular No. Circular no. 2021-002 Re: 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 Circular for comments amending FDA
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
