Adapting Regulatory Artwork for Advanced Therapy Medicinal Products (ATMPs)
Advanced Therapy Medicinal Products (ATMPs) represent a cutting-edge approach to medicine, harnessing the power of cells, tissues, or genes to treat a variety of ailments. Due to their complexity and novelty, regulatory requirements for Advanced Therapy Medicinal Products (ATMPs) are understandably stringent. This extends to the artwork included in regulatory submissions, which plays a crucial role in conveying critical information clearly and concisely.
Navigating the Cosmetic Regulatory Landscape in Thailand
The cosmetic market in Thailand is a thriving one, offering a diverse range of beauty and personal care products. The country has established a comprehensive Regulatory framework to ensure consumer safety and uphold product quality. Thus, manufacturers, importers, and consumers must understand the cosmetic Regulatory scenario in Thailand before launching their products.
Navigating the Cosmetic Regulatory Landscape in Vietnam
The cosmetic market in Vietnam is a flourishing one, offering a diverse range of beauty and personal care products. The country has established a comprehensive Regulatory framework to ensure consumer safety and uphold product quality. Thus, manufacturers, importers, and consumers must understand the cosmetic Regulatory scenario in Vietnam before setting forth to launch their products.
Open configuration options CE-marked Devices and the Great Britain Market Strategy
Post the Brexit scenario, the Regulatory landscape for medical devices in the United Kingdom (UK) underwent a profound metamorphosis, significantly impacting manufacturers aiming to introduce their products. As the UK made an exit from the European Union (EU), there was a shift from Conformité Européenne (CE) marking to UK Conformity Assessed (UKCA) marking. However, presently, the Medicines and Healthcare products Regulatory Agency (MHRA) still allows the placing of CE-marked devices on the UK market.
Current Regulatory Scenario for Medical Devices in the UK
The current Regulatory scenario for medical devices in the United Kingdom (UK) is governed by the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended), also known as the UK MDR 2002. This framework was originally based on the European Union (EU) Directives, but following the UK’s exit from the EU, there have been changes to how medical devices are regulated in Great Britain (GB), comprising England, Wales, and Scotland.
Here are the key points with respect to the current Regulatory scenario for medical devices in the UK:
Common Specifics for Medical Devices for Intended Purposes
The specifics for medical devices refer to a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This includes the type of medical conditions the device is designed to diagnose, treat, monitor, alleviate, or prevent.
Understanding Personalized Medical Devices: Their Verification and Validation
In the ever-evolving healthcare landscape, personalized medical devices have emerged as a groundbreaking approach, tailoring treatments to individual patients based on their unique characteristics. These include devices that are custom-made or personalized to be adaptable to the patients’ solutions.
Inside the EU MDR/IVDR: A Closer Look at Sampling Devices
While placing your medical device on the European Union (EU) market, obtaining CE marking is a mandatory step. This is essential to assure the end user that the devices available in the market are both safe and effective for use. A critical component for providing this assurance involves a thorough examination of the technical documentation for the medical devices.