At StayGuard™, we understand the importance of completing product registration in a professional and efficient manner. Our Regulatory Affairs Department has vast experience with preparing documentation and samples for registration in countries across the globe.
Product registration and/or testing is a requirement of many national regulatory agencies. Adherence to such requirements, usually encompassing the verification of product quality, accurate documentation, and complaint packaging, is a condition before a medical product can be imported and freely distributed in a specific country. Some countries might not require registration, but instead rely on third-party agencies, such as SGS or BIVAC, to test or verify a product before importation. Still other countries remain unregulated for the importation of medical devices, for which our distributors rely on our quality control capabilities or are free to conduct inspections on their terms to ensure compliance.
Prior to the importation of our products, we will complete supplier and/or product registration with the relevant MOH (Ministry of Health) or government health authority. We provide required documents such as the Manufacturing License, Free Sales Certificate, analytical and technical data, and quality certifications including CE, ISO, USFDA, etc. In preparing and submitting such documentation, it is important to avoid delays from queries which hinder the entire registration process. Our Regulatory Affairs team employs established procedures that focus on attention to detail. Such tried and proven techniques accelerate the overall process, allowing our distributors to enter the market faster. Experience the difference in working with StayGuard™… see why 92% of distributors have been with us in excess of 5 years!
All terms and conditions between StayGuard™ and our distributor are clearly defined. final approval is attained and the Agreement is finalized.
Factory Inspection while rarely required for the registration of skin and wound care product with the MOH (Ministry of Health), or related health authority of the importing country, a facility inspection might be required.
We welcome MOH inspectors and officials to our facility and ensure close collaboration in order to meet all requirements.
All required documents are prepared and checked in order to proceed with the registration process.
Our products are manufactured using high quality materials and have been designed according to the extensive search and analysis, differentiating our branded products from others in the market.
Our product packaging can be altered to meet country-specific requirements for the clients.
The testing of samples is required from number of countries.
StayGuard™ samples are prepared in accordance to the registration requirements of the importing country and have been pre-tested in order to guarantee standard and compliance.
All required documentation, samples and any other necessary material are submitted for registration approval to the importing country's MOH or relevant health authority.
After the completion of the registration process, our Marketing Department collaborates closely with new distributor to provide our products in that specific market (i.e., promotional materials, strategic assistance, IT support, etc.)