It’s time to set sail | Keruichi has obtained overseas registration approval and ISO13485 quality management system certification

Clarity's interventional microcatheter set product has successfully passed the registration approval of Brazil's ANVISA, and the registration application for this time is zero reimbursement.

 

Recently, there have been many happy events for ClariCare Medical.

 

Clarity's interventional microcatheter set product has successfully passed the registration approval of Brazil's ANVISA, and the registration application for this time is zero reimbursement. This is also the first overseas medical device registration approved by Clarichis with independent research and development, independent intellectual property rights and independent brands, opening up a new battlefield for Clarichis Medical TACE full-process solution to officially enter the overseas market!

 

At the same time, after strict review by TÜV SÜD, an authoritative international testing and certification agency, the company successfully passed the ISO13485:2016 international quality system certification audit and obtained the certificate. This marks that ClariCare's medical quality management system has reached international standards and has the ability to provide products and technical services to customers in the global medical field, laying a solid foundation for the company's future development.

 

1. Brazil ANVISA registration approval

 

 

As the largest medical device market in South America, Brazil has a population of more than 200 million. Its GDP will grow by 4.6% in 2021, with a GDP of US$1.61 trillion and a per capita GDP of US$7,518.

 

The Brazilian National Health Regulatory Agency (ANVISA) is a health regulatory agency under the Ministry of Health of the Brazilian Federal Government and is responsible for approving the sales and use licenses of medical devices. Only registered medical devices are allowed to be sold and used in Brazil.

 

The microcatheter set product was approved in Brazil, which is a major milestone for Creichi to go overseas. It not only enriches the company's product line, extends the market reach to a greater breadth, significantly enhances the international brand influence and market position of Creativity, and provides new momentum for commercial expansion.

 

2. ISO13485: 2016 international quality system certification

 

 

The ISO13485 system is a medical device quality management system standard formulated by the International Organization for Standardization (ISO). This system is based on the ISO9001 standard and adds special requirements for the medical device industry. It focuses on the design and development, production, storage and storage of medical devices. Organizations in related industries such as circulation, installation, service and final decommissioning and disposal aim to standardize the quality management process of medical device manufacturers, suppliers and related service providers to ensure that products comply with industry regulations and customer requirements.

 

The certification body conducted a comprehensive and strict review of the company's quality management system, management responsibilities, resource management, product realization, and measurement, analysis, and improvement. In the end, the audit team spoke highly of the company's quality management system, saying that the company's overall quality management system was operating well and all tasks met regulatory requirements.

 

 

The passing of the ISO13485: 2016 international quality system certification and the approval of the Brazilian ANVISA registration license have greatly enhanced the confidence and determination of Creativity Medical to enter overseas markets.

 

ClariSci Medical will continue to adhere to the concept of "based on therapeutic reading, reconstruct the local immune ecology, and build targeted treatment devices and drug delivery systems for sequential cell apoptosis and death", zero-point connection between clinical needs and engineering technology, and provide Operators provide intelligent tools to respond to clinical challenges, helping more domestic patients relieve pain and prolong life. At the same time, they further actively explore overseas markets, support innovative development in the global medical and health field, and make greater contributions to building a community with a shared future for mankind.