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Medical Devices-Asia and ROW Regulatory News-July 2023

July 25, 2023
Medical Device

ASIA SINGAPORE (HSA) HSA’s SRA status for In-vitro Diagnostic Medical Devices (IVD) An SRA is a national health products regulatory authority considered by the WHO to apply stringent...

Asia Regulatory News, IVD, Medical Devices, Regulatory News, ROW Regulatory News

Regulatory Intelligence shows path to the Success in Pharma Industry

July 21, 2023
Biopharma

Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture and release products into the market. Companies have to analyze, monitor and gather the information...

Compliance, Healthcare, Medical Devices, Pharma Industry, Regulatory Intelligence, Regulatory Updates

Pharma/Biotech – USA, Europe Regulatory News, July 2023 Vol. 1

July 12, 2023
Biopharma

USA No Big-Picture Impact for Manufacturers in CMS IRA Updates In the face of multiple lawsuits and 7,500 public comments, CMS adjusted some aspects of the Inflation Reduction Act’s drug price...

Biotech Regulatory News, EMA, EU Regulatory News, FDA, GCP Guideline, MHRA, Pharma Regulatory News, Regulatory News, RWD, RWE, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-July 2023

July 11, 2023
Medical Device

USA (FDA) Content of Premarket Submissions for Device Software Functions The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software...

Europe Regulatory News, FDA, HPRA, Medical Devices, MHRA, Premarket Approval (PMA), Regulatory News, USA Regulatory News

What Pharma Companies need to know about EU MDR Regulations?

July 6, 2023
Biopharma

EU MDR The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices The EU MDR entered into application on 26 May 2021 REGULATION...

Compliance, EU MDR, Medical Device Regulations, Pharmaceutical Industry, Regulatory Affairs

ANVISA New Medical Device Regulation RDC 751/2022

June 27, 2023
Medical Device

On March 1st, 2023, the new RDC (Resolution of the Collegiate Board) 751/2022 released by the Brazilian National Health Surveillance Agency (ANVISA) went into force. The fundamental goal of the...

ANVISA, Brazil Healthcare, Compliance Standards, EU MDR Regulation, Medical Device Regulation, RDC751, SaMD