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Ensuring Compliance and Quality: The Role of CE Marking in Safeguarding Patient Safety
The CE marking signifies a medical device's adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By...
EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe
Introduction about Medical Device Regulation in Europe Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness. The need for the MDR...
Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry
In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating the path to market access are crucial tasks. Amidst this complexity, one key player stands out: the Authorized Representative (AR). ARs are recognized...
Regulations
EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe
Introduction about Medical Device Regulation in Europe Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness....
Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023
Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them...
Software As a Medical Device and Its Clinical Evaluation
Software as a medical device (SaMD) refers to a class of medical software that performs one or more medical tasks independently of a physical medical device. It can interface with other medical equipment or software or be utilised with non-medical computer platforms like smartphones. It may be used for a number of objectives, including illness detection, diagnosis, treatment, or prevention. The quality of life for patients and providers can be enhanced through its interactions with data. Regulation is necessary for SaMD since it is a novel and creative technology that must be safe.
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Registrations
Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
TFDA Requirements for Summary Product Characteristic (SPC) Name of the Medical Product Qualitative And Quantitative Composition Pharmaceutical Form Clinical Particulars Therapeutic indications Posology and method of...
Overhauling Drug Registration: The Indonesian Food and Drug Authority’s Progressive Amendment
Drug Registration - The Indonesian Food and Drug Authority (BPOM) plays a crucial role in ensuring the safety and efficacy of pharmaceuticals within the Republic of Indonesia. In 2019, the BPOM made a significant stride towards enhancing public...
Comprehensive Guide to Pharmaceutical Registration in Indonesia: BPOM, Regulations, and Approval Pathways
Territory: Southeast Asia Official Language: Indonesian/English Regulatory Authority Name: Badan Pengawas Obat dan Makanan (BPOM) Regulatory Authority website: https://www.pom.go.id/ Mail ID: [email protected] ...
Authorised Representatives
Nomenclature of Medical Devices
‘Medical devices’ is an umbrella term that includes products for the prevention, diagnosis, and treatment of numerous diseases. Medical devices require an internationally accepted naming to identify the various types and categories. Nomenclature of medical devices helps understand the medical device’s risk class, definition, and use.
Labelling Requirements – Swiss Authorized Representative
Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for...
Swiss Manufacturer Obligations
1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technical documentation for the devices, to comply with the requirements of the ordinance, and to...