Remove 03 24 contracts-global-access-to-medicines
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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.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

The measure may allow the expansion of the population’s access to diagnostic procedures in the country. In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations.

FDA 40
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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

During a visit to the establishments, evidence of the manufacture of herbal medicines without registration and with a fraudulent label was observed, as the materials were produced in an environment with inadequate hygiene and sanitary conditions. To be injectable, the product must be registered with the Agency as a medicine or health product.

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