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Directive (EU) 2019/904 on the reduction of the Impact of certain Plastic Products on the Environment
Introduction Directive 2019/904 aims to mitigate the environmental and health impacts of specific plastic products, particularly in aquatic environments, while fostering the transition towards a circular economy through innovative and sustainable practices. It...
Iraq Medical Device Registration: KIMADIA Guidelines and Requirements
Navigating Medical Device Registration with Iraq's Regulatory Authority: KIMADIA Guidelines and Requirements Regulatory Authority: State Company for Marketing Drugs and Medical Appliances (KIMADIA) "Kimadia" refers to the Iraqi State Company for Marketing...
License Transfer for Medical Device to New Sponsors from Existing License Holders
License transfer for medical devices is a crucial aspect of the regulatory landscape governing the manufacturing and distribution of medical products. It allows existing license holders to transfer the rights to manufacture and market a specific medical device to a...
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
Iraq Medical Device Registration: KIMADIA Guidelines and Requirements
Navigating Medical Device Registration with Iraq's Regulatory Authority: KIMADIA Guidelines and Requirements Regulatory Authority: State Company for Marketing Drugs and Medical Appliances (KIMADIA) "Kimadia" refers to the Iraqi State...
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...
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...