Launching Food for Special Medical Purposes (FSMP) in China requires a profound understanding of the Regulatory landscape of the food and dietary supplement market. Governed by the State Administration for Market Regulation (SAMR), the FSMP rules are carefully designed to safeguard the safety, quality, and efficacy of specialized food products tailored for individuals with specific medical conditions.
- April 10, 2024 Food and Food Supplements
- April 4, 2024 Pharmaceuticals, Regulatory Artwork Services
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.
- April 3, 2024 Cosmetics Regulatory Services, Regulatory Affairs
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.
- April 3, 2024 Cosmetics Regulatory Services, Regulatory Affairs
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.
- March 29, 2024 Medical Devices, Regulatory Affairs
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.
- March 29, 2024 Medical Devices, Regulatory Affairs
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.
- March 29, 2024 Medical Devices, Regulatory Affairs
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.
- March 29, 2024 Medical Devices, Regulatory Affairs
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.
- March 29, 2024 Medical 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.
- March 28, 2024 Publishing & Submissions, Regulatory Software & Services
The global race to bring new drugs and medical devices to market has fuelled the rise of parallel submissions – a strategy where companies file applications with Regulatory agencies in multiple countries concurrently. A recent study by Tufts Center for the Study of Drug Development found that parallel submissions for new drugs can reduce approval timelines by an average of 9 months.