Good Distribution Practice Certification for Medical Devices YA 1348

System of Principles & Guidelines for the Good Distribution Practice of Medical Devices.

What is the assessment process for businesses?

The assessment of compliance with the requirements of the Ministerial Decision takes place following an assessment visit by a specialized Notified Body Assessorin the field of medical devices.

The assessment process includes checking the Business's compliance with the legal requirements of the Ministerial Decision.

Upon successful completion of the audit, the Notified Body issues a Certificate of Compliance.

What are the benefits?

The most important benefit is compliance with the requirements of the legislation regarding the obligation of all Businesses distributing medical devices to hold a Certificate of Compliance for for the distribution of their products.

Additional reasons that lead Businesses to implement the Ministerial Decision are:

• They can participate in public sector tenders, in which the Certificate of implementation of the Ministerial Decision is included in the required participation documents.
• Growth of commercial transactions with customers and/or suppliers who wish to partner with businesses that comply with the requirements of the Ministerial Decision.
• Standardization of operating procedures, so that errors and failures are limited.
• Improvedperformance of the personnel involved.

The NOVITAS is in a position to support you, development, implementation and certification in accordance with Joint Ministerial Decision 1348.