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MDSAP CONFORMITY CERTIFICATE Certificate No. NCC 22.09498Revision n: 00Date of Issue: 13/09/2022Expiration date: 13/09/2025NCC Certificaes do Brasil Ltda., an MDSAP authorized Auditing Organization,

How to fill out mdsap conformity certificate

How to fill out mdsap conformity certificate

1. Start by gathering all necessary documentation related to your medical device, including design, manufacturing, and quality management system information.
2. Identify the applicable regulatory requirements for the countries involved in the Medical Device Single Audit Program (MDSAP).
3. Complete the MDSAP Application Form with accurate details about your organization and the medical devices for which you seek certification.
4. Engage an authorized MDSAP certification body to conduct an audit of your quality management system.
5. Prepare for the audit by conducting internal audits and ensuring all documentation and processes are in compliance with MDSAP requirements.
6. Undergo the audit conducted by the chosen certification body, who will assess compliance with the MDSAP criteria.
7. Address any nonconformities identified by the auditor and implement corrective actions as needed.
8. Upon successful completion of the audit and resolution of any issues, the certification body will issue the MDSAP conformity certificate.

Who needs mdsap conformity certificate?

1. Manufacturers of medical devices that intend to market their products in multiple countries participating in the MDSAP program.
2. Organizations looking to streamline the audit process and demonstrate compliance with multiple regulatory authorities in one certificate.

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What is mdsap conformity certificate?

The MDSAP conformity certificate is a document that indicates that a medical device manufacturer complies with the regulatory requirements of multiple countries under the Medical Device Single Audit Program (MDSAP). This program allows organizations to demonstrate compliance with the regulations of participating countries through a single audit.

Who is required to file mdsap conformity certificate?

Manufacturers of medical devices who wish to market their products in participating countries, such as the United States, Canada, Brazil, Australia, and Japan, are required to obtain and file an MDSAP conformity certificate.

How to fill out mdsap conformity certificate?

To fill out an MDSAP conformity certificate, manufacturers must follow the guidelines provided by their auditing organization, which includes supplying accurate information regarding their quality management system, compliance to regulatory requirements, and any necessary supporting documentation.

What is the purpose of mdsap conformity certificate?

The purpose of the MDSAP conformity certificate is to streamline the regulatory process for medical device manufacturers by allowing them to undergo a single audit, thus facilitating market access in multiple countries while ensuring compliance with their regulations.

What information must be reported on mdsap conformity certificate?

The MDSAP conformity certificate must report the manufacturer's name, address, and details of the medical devices being certified, the scope of the audit, the date of the audit, any findings and observations, and the certification status, as well as any applicable regulatory references.