SS 620 Good Distribution Practice for Medical Devices (GDPMDS) is an accreditation for organizations associated with capacity, exchange, and conveyance of clinical gadgets. GDPMDS guaranteed organizations have set up methods and cycles to guarantee that clinical gadgets are appropriately put away, moved, and dealt with under reasonable conditions according to administrative necessities or product specification.

Organizations need to set up, create, keep up and control conveyance exercises and cycles to guarantee the quality and honesty of clinical gadgets all through the circulation measures.

How can Aceteam Management Consultancy help you and your organization?

Ensure clients are aware of and comply with the latest regulatory requirements set by the Health Sciences Authority (HSA) for the distribution of medical devices in Singapore.
Help establish and implement a robust Quality Management System tailored to the distribution of medical devices, incorporating GDP principles.
Develop and implement effective documentation and record-keeping processes to ensure compliance with regulatory standards.
Provide training programs for personnel involved in the distribution process, covering regulatory requirements, GDP principles, and best practices.
Advise on proper storage and transportation conditions to maintain the quality, safety, and efficacy of medical devices throughout the distribution chain.
Assist in the implementation of traceability systems, ensuring the effective tracking and identification of medical devices at each stage of distribution.
Develop and implement procedures for handling complaints and initiating product recalls, if necessary, in accordance with regulatory requirements.
Establish systems for continuous monitoring of compliance with regulatory standards, providing ongoing support to address any emerging issues.
Conduct a comprehensive gap analysis of current distribution practices against GDPMDS requirements and provide recommendations for remediation.
Conduct internal audits to assess the effectiveness of the implemented Quality Management System and ensure ongoing compliance with GDPMDS.
Provide guidance on aligning distribution practices with international standards, such as ISO 13485, to enhance global competitiveness.