Before starting to market a medical device in foreign countries, there is a need to undergo a registration process at the Health Authorities to check its safety and quality and at the end of this process a marketing approval may be obtained.

Our regulatory affairs team has the expertise, long-term experience preparing and compiling the registration dossiers for all categories of medical devices and IVDs in line with the latest regulatory requirements in multiple countries before submitting them to the appropriate health authorities.

Barrco Regulatory Solutions with teams of local experts can develop the appropriate regularly intelligence, strategy and pathway for the registration of your devices and in-vitro diagnostics in different markets. Our main goal is to assist you to successfully surpass all obstacles leading up to receiving an approval from the Health Authorities for marketing your medical device. Emphasis is placed on quality performance of regulatory activities prior to the submission requesting registration, submitting a request according to the Health Authorities standards, organized monitoring throughout the evaluation process by the medical device unit in the Health Authorities, to ensure quick registration in the National Medicine Registries.

Barrco Regulatory Solutions offer the following solutions in order to comply with the requirements of the Health Authorities, obtain licenses that will enable you to quickly launch your medical device, and to handle the maintenance of the licenses in the best manner:

– Preparing and submitting requests for registration of a medical device, registration renewal (license extension) of a medical device, and variations of the registration conditions in Europe and the USA, Asean countries, CIS Russia and African countries, including preparation of the CE file.

– Efficient monitoring throughout the evaluation process at the Health Authorities up to obtaining the approval.

– Professional translation to native languages of some countries – English- Arabic- Russian. – Graphic design and printing of leaflets, packages, labels.

– Obtaining a onetime import permit and an importing certificate.

– Continuous or temporary management of the registration field according to your needs.

– Choosing a strategy suitable for the registration of a medical device in Israel and internationally.

– Training the company’s management team regarding the regulatory aspects of the medical device regulatory field.

– Updating the management regarding changes in the legislation and the guidelines of the medical device unit.

– Obtaining a certificate for exporting a medical device.

– Support and preparation for certification for the ISO 9001 quality standard and ISO 13485.

Due to the professionalism, the vast experience and the excellent working relations with the authorities, our company’s customers have expanded the quantity of medical devices that they market, which has led to growth in their business activities worldwide.

In a lot of countries, the documents need to submit not in English, but in their native languages. For example- in Russia and Russian speaking countries, some Asian countries like China, South Korea, Japan ect, American countries like Brazil, Mexico ect and most European countries.  Our translation team can translate the full dossier, and make the dossier as per local requirement.