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GDPMDS (SS 620) Consultancy in Singapore
Established in Singapore in 1992, CCIS has helped many organisations achieve ISO, Singapore Standards (SS) and bizSAFE certification, as well as other compliance goals.
- 1992Established in Singapore
- 30+Years of management systems expertise
- 20,000+Companies served
- S$400KPaid-up capital in Singapore
What is GDPMDS?
GDPMDS is the Good Distribution Practice for Medical Devices, specified in Singapore Standard SS 620. It covers how medical devices are received, stored, delivered, traced and recalled, so that their quality is maintained throughout distribution.
How CCIS helps you achieve GDPMDS certification
- Gap analysisWe assess your current distribution practices against SS 620
- Storage and handlingWe guide your team in establishing the controls required by SS 620
- Traceability, recalls and complaintsWe guide your team in developing the procedures for traceability, recalls and complaints
- Implementation and trainingWe train your team on how to implement the procedures
- Internal auditCCIS conducts the internal audit to confirm readiness for certification
- Certification audit preparationWe prepare you for the independent certification body’s audit and advise on any findings
Optional maintenance support is available after certification.
Why organisations choose CCIS
- More than 30 years of quality management experience in Singapore
- “Write what you do, do what you write”: a system your team understands and can maintain
- Able to integrate with ISO 13485, ISO 9001 and other standards as one system
- Integrated management systems since the 1990s, featured in the national newspaper in 1998 for a first-of-its-kind certified IMS in the region
GDPMDS questions
Which organisations need GDPMDS certification?
Medical device importers and wholesalers in Singapore generally require GDPMDS certification for their dealer licences from the Health Sciences Authority. Please refer to HSA’s current requirements for your licence.
How does GDPMDS differ from ISO 13485?
GDPMDS covers distribution activities. ISO 13485 covers the complete quality management system of organisations that design or manufacture devices.
Can GDPMDS be combined with ISO 9001 or ISO 13485?
Yes. Many distributors operate GDPMDS within their ISO 9001 or ISO 13485 system.
Related medical device services
Talk to a GDPMDS consultant
Tell us about your distribution operations and we will recommend the right starting point.
- Tell us about your organisationYour scope, sites and current practices
- We recommend a starting pointA gap analysis or a full certification project
- You receive a proposalWith the scope, approach and timeline
Talk to our team
Tell us which standard, course or audit you require, and we will explain the steps and the support suited to your organisation.