Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

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Borderline Medical Devices: Ensuring Regulatory Clarity for Public Health and Market Integrity

EU's Manual on borderline medical devices clarifies classification rules, ensuring public health safety & market integrity

Maria

Application of ISO/IEC 17021-1 in ISO 13485

ISO 13485 certification demands strict adherence to ISO/IEC 17021-1:2015, ensuring QMS quality in medical devices.

Maria

MoCRA - FDA and Cosmetics regulation

FDA MoCRA brings new regulations for the US cosmetics registrations.

Maria

New UK Post-Market Surveillance (PMS) Rules for Medical Devices

UK PMS Regulation is essential for medical device manufacturers.

Maria

SaMD and AI in the UK

The UK's "Software and AI as a Medical Device Change Programme" seeks to ensure safe, clear, and innovative regulation for healthcare SaMD

Maria

AF Pharma Shines at CPhI Worldwide: A Pinnacle of Pharmaceutical Excellence

AF Pharma made waves at CPhI Worldwide 2023, showcasing innovation, networking, and earning industry recognition.

pharmaserviceinc

New EU Borderline guidance

Explore the updated Manual on Borderline Classification for EU Medical Devices (Version 3 - September 2023) and ensure compliance.

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FDA Rule Change Sees Laboratory Developed Tests Regulated as Medical Devices

"Learn how the FDA's new rule classifying Laboratory Developed Tests as medical devices impacts healthcare, and how AF Pharma can help you

pharmaserviceinc

Israel's AMAR Regulatory Changes for Medical Devices: A Leap Towards Streamlined Approvals

Discover Israel's new medical device regulations - AMAR system simplifies approvals, expands reference countries, and fosters innovation

Soledad

Real World Data - FDA Guidelines

Real-world data, as per FDA guidelines, plays a pivotal role in enhancing drug safety and effectiveness assessments, informing healthcare.

Soledad

MHRA Decision Aid: MDR Extended Transitional Period Coverage Assessment

MHRA generated a flowchart to assist in deciding whether or not a medical device is covered by the extended MDR transitional period.

Soledad

FDA - Medical Device Establishment Registration: 2024 fees

2024 MDUFA fees. The new Medical Device Establishment Registration for 2024 is $7,593.00.

Soledad

US FDA Medical Device Establishment Registration

US FDA Medical Device Establishment Registration is the process where medical devices facilities are registered in the US FDA.

pharmaserviceinc

UK's Software and AI as a Medical Device Change Programme

In today's technologically driven world, software, including Artificial Intelligence (AI), is revolutionizing various industries,...

pharmaserviceinc

Draft UK Post-market Surveillance Requirements

We have some exciting news to share regarding the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has recently...

Soledad

Title: AF Pharma: Your Trusted FDA US Agent Partner for Global Market Access

US Agent and FDA support

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Medical Device Development with MDDT Qualification

FDA GUIDANCE: Qualification of Medical Device Development Tools Guidance for Industry, Tool Developers, and FDA documents.

Soledad

MHRA - Template Letter for EU Article 120 Extension Confirmation

MHRA Updates Guidance and Template Letter for EU Article 120 Extension Confirmation

Soledad

Legacy Devices with Expired Certificates

MDCG 2022-18 position paper on Article 97 MDR for expired MDD/AIMDD certificates is now irrelevant due to new regulations (EU) 2023/607.

Soledad

Import Medical Devices to Brazil

Importing medical devices to Brazil involves following specific procedures and adhering to regulatory requirements set forth by ANVISA.