According to CQC, CQC- registration is required for manufacturers, importers, and distributors of medical devices in the United Kingdom (UK). The CQC is a part of the Medicines and Healthcare products Regulatory Agency (MHRA), a UK government agency responsible for ensuring that healthcare products are safe and work as intended. CQC is an acronym for the Clinical Quality Consensus. The CQC was created to help bring medical device regulation up to European Union (EU) standards in the UK. The European Union (EU) has established many guidelines and regulations for medical devices to make the entire continent conform to a harmonised approach. For example, the EU created a standard regulatory system regarding in vitro diagnostic medical devices. In 2003 updated their guidelines to become more stringent regarding clinical investigation and assessment of these devices.
What Is The Purpose Of The Registration Of CQC?
CQC Registration aims to ensure that medical devices are safe and will function as intended. CQC- registration is required for medical device manufacturers, importers, and distributors in the UK.
Is CQC- Registration Mandatory? Yes. For distributors, importers, and manufacturers of medical devices in the UK, registration with the CQC is mandatory.
When was CQC-Registration Required? CQC- registration became mandatory for manufacturers, importers, and distributors of medical devices in the UK on October 1, 2009.
Why Is CQC-Registration Mandatory?
According to a press release from the CQC about their briefing for industry, “CQC Registration is an opportunity for you to demonstrate your commitment to patient safety, and that of the products you produce or distribute.” The press release goes on to say, “As an entity within MHRA, the CQC will be working with industry to improve patient safety – through improved regulatory compliance, but also by
encouraging approaches that lead to improved documentation, training, and staff behaviors.”
How Do I Register?
To register online, visit the CQC website. The first step is to complete an application form which will ask you about your company and its products. Once you have completed the application form, submit it to CQC and pay the registration fee.
What Are The Requirements? All UK manufacturers, distributors, and importers of medical devices must register with CQC.
Who Is CQC-Registration Required For? The CQC-registration requirements apply to all UK manufacturers, distributors, and importers of medical devices.
How Much Does It Cost? Registration costs £263 for your first year of registration, with subsequent years costing £163. However, if you have two or more manufacturers or importers named on your registration, you will pay only £526 for the first year, with subsequent years costing £326.
Conclusion
Registering for CQC- registration takes about 15 minutes—a small commitment that could help protect patients’ health. For more information, visit the CQC website. For more information on medical device safety, visit the AdvaMed (Advanced Medical Technology Association) website.
