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
The Malaysian Medical Device Authority (MDA) has released guidance on the requirements for registering Refurbished Medical Devices (MD/GD/0060). The guidance document provides information on how to register a refurbished medical device before it can be placed in the Malaysian market. What is a refurbished medical device? According to the ASEAN
Malaysia’s Medical Device Authority (MDA) has released draft guidance for the classification of rehabilitation, physiotherapy and speech therapy devices. Industry stakeholders are invited to comment on the draft guidelines until 2 March 2022. The guidance states that the classification as a medical device will be made upon the clear indication
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