As the largest end market in the Middle East, Saudi Arabia ranks first in per capita healthcare expenditure in the region. In 2020, the government budget allocated 167 billion rials (approximately $44.5 billion) for the healthcare industry. However, local companies in Saudi Arabia are mainly engaged in manufacturing consumables or serving as distributors for foreign companies, and most medical devices are usually imported from other countries. Therefore, the medical device market in Saudi Arabia is very large. DEKRA Certification UK Ltd has been confirmed by the Medicines, Technology and Healthcare Products Regulatory Agency (MHRA) as one of four UK certification bodies currently dedicated to the certification of UK medical devices to ensure the safety and effectiveness of devices safely provided to the UK public. 
DEKRA has become the first organisation to complete the newly designated process, which any potential organisation must now go through before being allowed to certify medical devices in the UK. Certification bodies are MHRA-appointed organisations responsible for assessing whether manufacturers and their medical devices comply with the UK Medical Devices Regulations 2002. Manufacturers were required to apply to UK certifiers for certification except for equipment with minimal risk. Only after UK Conformity Assessment (UKCA) was Assessed could their products be sold in the UK market (England, Wales and Scotland). After appropriate assessment, an approved certification body may certify the product, allowing the manufacturer to affix the UKCA mark to its certified products. MHRA officer Laura Squire said: “This is an important milestone in ensuring that patients across the UK have access to high quality medical devices. Certifying bodies play a key role in the supply of medical devices and expanding capacity is crucial to the successful development of the UK’s medical device regulatory regime.” The MHRA’s detailed evaluation process is designed to ensure that any organization wishing to certify a medical device can conduct a fair and objective evaluation and has an appropriate quality control system and adequate resources. The MHRA is currently assessing applications from six other organisations to become accrediting bodies. (Source: National Trade Bureau, Ministry of Economic Affairs) At present, SEJOY SARS-CoV-2 Test Cassette have obtained MHRA certification and can be sold in the United Kingdom. Welcome to inquire from major distributors in United Kingdom. poct@sejoy.com 0571-81957782 https://www.sejoy.com/covid-19-solution-products/ 
Our biochemical department was established in 2009, and the immune chromatography platform was established in 2015. Relying on a strong research and development team, we have gradually established three major product lines: eugenics, drugs, and infectious diseases. The three major product lines have now established a complete industrialization system for research and development, production, and sales. We provide a rich range of biological diagnostic products for users around the world. In the future, platforms such as tumor markers and myocardial markers will be established to continuously enrich the product line and provide customers with high-quality products and solutions. In order to fight against the epidemic, Sejoy launched the following four COVID-19 diagnostic test kits to reduce the impact of the epidemic. The COVID-19 lgG/lgM rapid test, SARS-CoV-2 antigen rapid test, SARS-CoV-2 neutralizing antibody test, and influenza test kit are all developed to help users take preventive measures in advance and reduce the risk of infection. Among them, the SARS-CoV-2 antigen rapid test has passed the Paul Ehrlich – Institut (PEI) test by the German authority for its excellent performance. Our SARS-CoV-2 antigen rapid test is easy to use, and the results can be obtained quickly in 10 minutes, with high sensitivity and specificity. As a result, we have become the earliest manufacturer in the industry to obtain EU CE certification for self tested products. Our company will continue to practice the corporate mission of “creating first-class products and caring for human health”, and provide customers with higher quality services!
Post time: May-06-2023