Good Distribution Practice (For Medical Devices)
Medical devices manufactured under controlled conditions and to exacting certification standards can be adversely affected by a lack of adequate control once they enter the storage and distribution process. Ensuring your organization offers the best service – and can prove it – is achievable through a quality system known as Good Distribution Practice for Medical Devices (GDPMDS).
SGS’s experience in the medical devices and supply chain market make us your ideal partner to audit you against the required standards. It is likely to be based on ISO 13485:2003 certification and will have strong similarities with EU, FDA and WHO guidance on Good Distribution Practice for pharmaceuticals.
Several national schemes for the GDPMDS exist, but there is currently no international standard available specifically for distribution. With our experience with schemes such as the Singapore Good Distribution Practice for Medical Devices, our established network of medical devices auditors can deliver an appropriate audit.
We can apply ISO 13485:2003 directly and issue accredited certification. We can also help you, or an industry group, devise specific requirement documents that can then be used to form your audit criteria.
SGS Singapore is accredited by the Singapore Accreditation Council (SAC) for the local GDPMDS scheme and can offer this certification to enable distributors to apply for a Health Sciences Authority establishment license – importer and wholesaler.
With a strong reputation for technically correct advice and certification, we have the expert knowledge and a global network of auditors to help you achieve your objectives.
Implement good distribution practice for medical devices (GDPMDS) in your supply chain with SGS.Email us
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