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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices , which will come into force on 01 March 2023. audit trail). There was a total of 19 observations.

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SQA Regulatory Surveillance Summary 6 | Monthly Update 2021

SQA

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. Regulators in Europe have updated their implementation plan for sweeping new in-vitro diagnostic (IVD) medical device regulations taking effect in 2022. SQA Regulatory Surveillance Summary #6, 2021. In-house devices.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

China Tightens Regulation on Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs), 26 October 2023 On 23 October 2023, the NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs) (referred to as the Notice ), which took immediate effect.

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