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Name: Fillable Online Declaration of Conformity Ce-tf-001-02 Fax Email Print - pdfFiller
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This document certifies that the syringe produced by Anhui Kangda Medical Products Co., Ltd. complies with the relevant EC Council Directives and Standards for medical devices. It outlines the responsibilities

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How to fill out declaration of conformity

01

Identify the product you are declaring conformity for.

02

Gather all relevant information and documentation related to the product, including technical specifications and safety data.

03

Ensure that the product meets all applicable standards and regulations.

04

Fill out the declaration form, providing the necessary details such as the manufacturer's name, product identification, and compliance standards.

05

Include any supporting documentation that proves compliance.

06

Sign and date the declaration to confirm its authenticity.

07

Keep a copy of the signed declaration for your records.

Who needs declaration of conformity?

01

Manufacturers of products that must comply with specific safety, health, and environmental requirements.

02

Importers of goods that fall under regulatory compliance.

03

Distributors who are responsible for ensuring that products meet required standards before selling.

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What is declaration of conformity?

A declaration of conformity is a document that states that a product meets the necessary regulatory standards and requirements stipulated by relevant laws and directives.

Who is required to file declaration of conformity?

Manufacturers or importers of products that are subject to specific regulatory standards are typically required to file a declaration of conformity.

How to fill out declaration of conformity?

To fill out a declaration of conformity, the issuer must include details such as the product name, model number, applicable regulations, the manufacturer's details, and test results confirming compliance.

What is the purpose of declaration of conformity?

The purpose of a declaration of conformity is to provide assurance that a product complies with applicable laws, regulations, and standards before it is placed on the market.

What information must be reported on declaration of conformity?

The declaration must report information including the product identification, manufacturer details, standards applied, testing methods, and the signature of the responsible party.

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