SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 52

FDA Compliance Public Health World Health 52

SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. Description of appropriate compliance times for GMP regulations. Floor 9, No. 381(a)(3).

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

APRIL 30, 2021

The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance. These missions will allow the Commission to identify, and, if necessary, correct any non-compliance or weaknesses.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. 26 of 2014. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

JULY 8, 2022

536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13. World Health Organization (WHO). A new Annex 16 on the Certification by the Authorized Person and Batch Release. PIC/S Annex 13 has been revised based on EC Regulation No. Therapeutic Goods Administration (TGA).

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

FEBRUARY 26, 2024

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52

FDA Compliance COVID-19 Public Health 52