YA 1348 – Good Distribution Practice for Medical Devices
Medical device distribution system certification in compliance with Greek legislation
Ministerial Decision DY8d/G.P.OIK./1348/2004 establishes the principles and guidelines for good distribution practice of medical devices in Greece. Its goal is to ensure product quality and safety throughout the entire supply chain.
The certification applies to every company engaged in importing, distributing, intra-community movement, and exporting medical devices. Manufacturers distributing exclusively their own products are exempt.
Requirements cover quality management, storage, transportation, and traceability. Compliance ensures products are not degraded during distribution.
ARROW Consulting provides full support for YA 1348 implementation and certification, aligned with ISO 13485 requirements.
Who is this for
Medical device importers and distributors. Pharmaceutical warehouses and health wholesalers. Healthcare logistics companies. Any business involved in the medical device supply chain in Greece.
Key Benefits
Legal Compliance
Full alignment with Greek legislation for medical device distribution and EOF requirements.
Product Quality
Assurance that products maintain quality from supplier to end user.
Traceability
Complete product traceability at every stage of the supply chain.
Competitive Advantage
Credibility in partnerships with hospitals, clinics, and suppliers.
Integration with ISO 13485
Complementary certification strengthening the medical device quality management system.
Certification Process
Initial Assessment
Assessment of existing distribution processes and identification of gaps against YA 1348 requirements.
System Development
Design of storage, transportation, traceability, and quality management procedures.
Staff Training
Training of all involved personnel on new procedures and regulations.
Internal Audit
Conducting internal audit to verify proper implementation.
Certification
Audit by accredited body (EKAPTY, LRQA, BQC, EQA) and certificate issuance.
Frequently Asked Questions
Any company engaged in importing, distributing, and exporting medical devices. Manufacturers distributing exclusively their own products are exempt.
YA 1348 focuses on distribution, while ISO 13485 covers the entire lifecycle. The two certifications are complementary.
The typical duration is 3-6 months, depending on company size and maturity of existing processes.
Accredited bodies such as EKAPTY, LRQA, BQC, and EQA Hellas provide YA 1348 certification services.
It covers transportation conditions, temperature control, packaging, and traceability during medical device transportation.
Need YA 1348 certification?
Contact us for a free initial assessment of your distribution system.