Register Medical Devices

NMPA (National Medical Products Administration) supervise the safety of, medical devices and cosmetics in China. Therefore, if you are thinking of selling your products in China, you have need to register your medical devices/products in with China’s regulatory authority (China Food and Drug Administration-CFDA). The NMPA is responsible for registration of medical devices for the Chinese market. NMPA formulate the investigation and enforcement system for drugs, medical devices and cosmetics, and organize their implementation. NMPA has many strict regulations requirements. With our services, medical devices and pharmaceutical companies have access to and understand these regulations. Understanding the NMPA is crucial if your company plans or is interested in expanding to the Chinese market. Every regulatory body has its own rules and requirements that may differ from other countries.  ANTEX helps to provide all regulation and requirement information of NMPA. We monitor any NMPA policy changes to provide the latest regulation information so that companies.

The food and Drug Administration- FDA is federal agency of United States of America. FDA is responsible for protecting and promoting public health through the control and supervision of food safety, drugs, vaccines, dietary supplements, radiation-emitting electronics, medical devices, cosmetics and animal feed. If your product is approved by FDA, it shows that it has undergone the rigorous quality system process and FDA review. Benefits: High impact, Access to International Markets, Credibility, Access to Hospital Networks, Flexible Roadmap.  ANTEX services helps you to understand the regulations and requirements, and can register you with FDA. Once registered we will provide you with documented proof of registration along with your registration number.

Federal Service for Surveillance in Healthcare (Roszdravnadzor) is the federal service of the Russian Federation that exercises control and supervision functions in the field of health care. Medical devices are allowed for circulation on the territory of the Russian Federation after they have passed pre-market approval by Roszdravnadzor. During the procedure, the quality of the devices and their compliance with current norms and standards are inspected. Roszdravnadzor makes sure that only quality and safe medical devices are introduced into the Russian market. ANTEX have first-hand knowledge of all technical and regulatory requirements for entry into the Russia that will help your organisation to sell your products in Russian market.

Brazil represents the largest market for medical devices in South America. The National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) is responsible for reviewing and approving clinical trial applications for drugs to be registered in Brazil. In the federal public regulatory structure, the agency is connected to the Ministry of Health. ANVISA’s primary goal is to protect and promote public health, by exercising health surveillance over products and services, including processes, ingredients, and technologies that pose any health risks. It is helpful to know the regulatory institutions that are involved with the clinical trials conducted in Brazil and to be aware of related documents. However, the process involves significant Regulatory challenges right from the requirement of authorized representative to filings to approvals, ANTEX can offer you a service to demonstrate compliance for your medical devices within the Brazilian market.

ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is responsible for approval of medical products, medicine, medical devices, reactants for diagnose, cosmetics, dietary supplements and food in the market of Argentina. It was established in 1992 and it has jurisdiction over the whole national territory. Currently, the ANMAT is in charge of the protection of human health by ensuring efficiency, safety and quality of medicine, food and medical devices in whole country. In order to register a product with ANMAT, it is required that Good Manufacturing Practice (GMP) standards are met and applicants must also provide a full history of previous commercialization of the device in other countries. Manufacturers must prepare technical documentation regarding their device and include the full information along with the application. ANTEX services helps you to understand the regulations and requirements, and can register you with ANMAT.