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Certification in a professional way,

Kcertification

We are ready to help your company obtain certifications in a professional way, ANATEL and INMETRO certified products in Brazil

Trusted by 1600+ Companies

We oversee the certification process from start to finish, sparing our clients from any concerns. Trust us with the certification of your medical and/or electromedical product or device.

3-Step Process to Get your product certified

Learn How it Works in Three Simple Steps - Here's How
challenges
"If you need to certify your product and don't know how, we offer the best and fastest solution, cost-effective and tailored to your organization.
Documentation
We develop and adjust all the technical information and documentation.
Product certified
We manage and oversee every detail with all parties involved (Certification Bodies, Laboratories, Manufacturers, and INMETRO and ANATEL).

Your product certified quickly, safely, and cost-effectively."
Safety and Quality Assurance:
Certification ensures that medical products meet specific safety and quality standards, reducing the risk of harm to patients and users.
Market Access
Certification often facilitates market access, both domestically and internationally, as many regulatory authorities and healthcare providers require certified products.

Accelerate Your

Product certification process with Kcertification.

Compliance
Certification helps manufacturers comply with regulatory requirements and industry standards, reducing legal and financial risks associated with non-compliance.
Competitive Advantage
Certified medical products may enjoy a competitive edge in the market, as certification signals reliability and adherence to recognized standards.
Patient and Provider Confidence
Certification builds trust among patients, healthcare providers, and other stakeholders, enhancing the reputation of the product and the manufacturer.

FAQ - Frequently Asked Questions

Get answers to your questions about medical and electromedical devices!

What is Inmetro with respect medical devices?

INMETRO (National Institute of Metrology, Quality, and Technology) is a Brazilian government agency responsible for the certification and standardization of products in Brazil. INMETRO plays a crucial role in ensuring that products meet safety, quality, and performance standards. It establishes the criteria and requirements that products must meet before they can be sold in the Brazilian market.

INMETRO certification is mandatory for various products, including electrical appliances, automotive components, toys, and medical devices, to name a few. This certification process involves rigorous testing and evaluation to ensure that products comply with established standards, thereby guaranteeing consumer safety and product quality.

In summary, INMETRO is a regulatory authority in Brazil that oversees and enforces product certification to protect consumers and ensure that products meet established standards of safety and quality.

What is ANATEL with respect to the product certification?

ANATEL stands for "Agência Nacional de Telecomunicações," which translates to the National Telecommunications Agency in English. ANATEL is the regulatory agency in Brazil responsible for regulating and supervising telecommunications services and products, including certification.

Regarding product certification, ANATEL requires that certain telecommunications equipment, such as cell phones, radios, and other wireless communication devices, undergo certification before they can be sold and used in Brazil. This certification ensures that these products meet specific technical and safety standards, comply with regulations, and do not interfere with the functioning of other telecommunications services. ANATEL certification is mandatory for such products to ensure they are safe and compatible with the country's telecommunications infrastructure.

In summary, ANATEL is the Brazilian regulatory authority that oversees and enforces certification for telecommunications products to ensure their quality, safety, and compliance with established standards and regulations.

How do I know if my product needs INMETRO certification?

Consult INMETRO's Product List: Visit the official website of INMETRO (www.inmetro.gov.br) and look for their list of regulated products. This list provides detailed information about the types of products that require certification. It is regularly updated to reflect changes in regulations.

Always get in touch with a professional company to helps you to get your product certified.

How do I know if my product needs ANATEL homologation?

Consult ANATEL's Product List: Visit the official website of ANATEL (www.anatel.gov.br) and look for their list of regulated products. This list provides detailed information about the types of telecommunications and radiofrequency equipment that require certification. ANATEL regularly updates this list to reflect changes in regulations.

Consult with Kcertification: Seek advice from us, consultants, and legal professionals with expertise in product certification and telecommunications regulations in Brazil. We  can provide valuable insights into the certification process and any recent changes in regulations.

How long time it takes to get my product certified?

We need to evaluate case by case to understand the needs and expectations of our clients, our commitment is to deliver a professional service with total efficiency and at a reduced cost.

How Kcertification can helps your company to obtain the certification?

We are experts in what we do, so:
We work to reduce the likelihood of errors in this process;
We work on management at all stages;
We've simplified the certification process;
Partnership with suppliers in all processes;
We provide full support in the certification process;
We audit and implement your management system in accordance with international standards such as (ISO 9001 and ISO 13485), but ANVISA, INMETRO and ANATEL regulations in all parts of the world with local professionals.

We are global

Our professionals are located in all parts of the world, we have partnerships with the main OCP's in Brazil and with the largest management system consulting and auditing company in South America (Klaston Management / www.klaston.com)

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Request a quote with us!

affordable prices for medical and electromedical devices certification in Brazil and around the world.