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Relaxed Regulations for Clinical Trials of Low-risk Medical Devices, Including AI, in South Korea
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Friday, January 22, 2021
Australia
Certain NICNAS Exemption Provisions Available Until August 31, 2022: Australia announced on December 17, 2020, that under the transitional arrangements, some exemption provisions that existed under the previous law, the Industrial Chemicals (Notification and Assessment) Act 1989, will be available to introducers until
August 31, 2022. Introductions made under this arrangement are taken to be Australian Industrial Chemicals Introduction Scheme (AICIS) “reported introductions” under Section 27 of the Industrial Chemicals Act 2019 (current law). Australia states that this means that if the introduction meets the criteria for one of the exemption provisions that existed under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), companies are authorized to introduce the chemical under AICIS as a “reported introduction” until
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We write to alert you to an important and imminent deadline. Consideration for confidential business information (CBI) for hazardous substance ingredient disclosure on safety data sheets (SDS) will require formal submission and approval in South Korea starting
January 16, 2021.
Background
On January 15, 2019, the South Korean government announced a major amendment to the South Korean Occupational Safety and Health Act (K-OSHA). The amendment requires that companies provide a copy of the SDS to the Ministry of Employment and Labor (MoEL), and if companies wish to maintain non-disclosure of confidential formulation details, they must provide for review and approval those details to the MoEL. There is a grace period for the submission for entities that have prepared or updated the SDS in accordance with Article 41(1) or (6) of the Act prior to the revisions. The grace period is based on manufacturing or importation volume
Monday, December 21, 2020
We write to alert you to an important and imminent deadline. Consideration for confidential business information (CBI) for hazardous substance ingredient disclosure on safety data sheets (SDS) will require formal submission and approval in South Korea starting
January 16, 2021.
Background
On January 15, 2019, the South Korean government announced a major amendment to the South Korean Occupational Safety and Health Act (K-OSHA). The amendment requires that companies provide a copy of the SDS to the Ministry of Employment and Labor (MoEL), and if companies wish to maintain non-disclosure of confidential formulation details, they must provide for review and approval those details to the MoEL. There is a grace period for the submission for entities that have prepared or updated the SDS in accordance with Article 41(1) or (6) of the Act prior to the revisions. The grace period is based on manufacturing or importation volumes.
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