Registration of medical devices is a complicated multi-stage process that requires specific knowledge and, most importantly, relevant experience. That is why registration of medical devices with the help of KS-PROF experts is a guaranteed result of obtaining a registration certificate in the shortest possible time, which is achieved by coordinated work of highly qualified experts with years of experience in the field of circulation of medical devices. Department of medical devices registration consists of 9 experts, including 2 candidates of technical sciences and 1 candidate of biological sciences.
SKF, SKF Medical Technologies and SWK Consulting provide consulting services. For example, advisory services of SKF Medical Technologies are conducted by experts in products, medical equipment, personnel, technical terms, quality, regulatory issues and procedures. Consultations are carried out by consulting specialists, who are responsible for technical compliance of products and medical devices. Consultations are conducted at different stages of product approval and they are subject to regulations issued by other authorities.
What are the existing regulatory requirements for medical devices?
The EU EC, ECJ, US FDA and Australian PMRC regulations regulate the performance and quality of medical devices. The UK Medical Devices Agency, the FDA, American FDA and Australian Health and Medical Devices Association (AHMDA) regulations require high standards and patient safety. So, compliance with various regulations is a key to the success of product launch.
According to the legislation, manufacturers of medical devices can get approval for certain products only within the framework of an authorised and participating party.
How do I obtain a registration certificate for a medical device?
Medicine registration is defined in Regulation 29(2) of the European Economic Community Directive 94/19. This regulation is currently in the registration phase and, as part of the conditions for registration of medical devices, it is required to provide information about certain issues including product name, operation and effect, origin, authority and approval, brand, class, form, class, country of origin and country of origin, plus specific additional elements, such as clinical evidence and compliance with regulations.
The CE/CE compliant equipment (Class 1), manufacturing processes (Class 2) and the components and products of medical devices (Class 3) need to have the CE/CE compliant mark on the label, while medical devices should have CE/CE compliant packaging. However, this is not mandatory. Companies may choose whether to get the CE/CE compliant mark on the packaging or not.
What kind of paperwork does this procedure require?
To obtain registration, you need to provide detailed information on the design and technical performance of the product and verify the compliance with regulations. Moreover, you need to verify the name, reference and function of each device that should be included in the product label. That’s why consultants recommended getting an additional report that defines device components and a process description.
What are the advantages of getting advice from specialists in medical devices? It is the best way to obtain a medical device registration certificate in the shortest possible time.
It reduces administrative burden and makes the product launch easier by eliminating relevant compliance requirements.