NCC Certificações

Medical Devices

For manufacturers of medical devices, dental and health which seek to access new markets anywhere in the world, or check the spread of safety and quality of its brand in the domestic market, the NCC and its national and international partners, in certifying products, are present to help them simplify the way and open new doors.

These manufacturers can rely on the NCC to meet the diverse technical requirements that are required in several countries. For the most attractive markets, we highlight the following marks:

 INMETRO mark for Brazilian market
 CE marking for European market
 NCC-Ar / S mark for Argentinian market
 FDA mark for United States
 C-CSA-us mark for American and Canadian market
 NOM mark for Mexican market
 CCC mark for Chinese market
 Certification of Quality Management System ISO 9001:2008 and ISO 13485

Inmetro mark for the Brazilian Market
This is a mandatory process for equipment regulated by Anvisa and also serves Inmetro Regulation

CE for Europe
The evolution of our work and the continued growth of the Brazilian market, contributed to the NCC seeks partnerships for the CE thus establishing, on April 27, 2005, a partnership with NEMKO Norway to meet the world market for electromedical products CE marking certification and management system for quality health care products ISO13485.
Currently, the NCC also maintains an operating agreement with the KEMA Quality

Argentina S Mark
The NCC has the support of an office in Argentina, accredited by the (FAO) for the issuance of S mark in all forms of certification (Batch Type and Inspection), giving all the support from start to finish the project.

Registration FDA for U.S. market
The FDA is the agency responsible for overseeing and regulating the health issue and health of the U.S., as well as Anvisa Brazil. Medical devices must be registered with that body so that they can be traded on the American territory. The NCC has global partnerships allowing for revision of the file 510 (K) in order to access the American market.

Many of our customers have joined the project 100% NCC, in which the NCC provides all services in a unified manner and with lower costs.