SS 620 GDP Certification for Medical Device Distributors
In Singapore, organizations involved in the import, scope, distribution, installation, servicing, and secondary assembly of medical devices are required to obtain SS 620:2016 Good Distribution Practice for Medical Devices (GDPMDS) certification prior to applying for Importer’s or Wholesaler’s Licence with the Health Sciences Authority (HSA).
What is SS 620:2016 (2021) Good Distribution Practice for Medical Devices?
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SS 620:2016 Good Distribution Practice for Medical Devices was developed by SPRING Singapore under the Singapore Standardization programme for organizations who are involved in wholesale and/ or importation of medical devices in Singapore as it is mandatory to have SS 620 GDPMDS certification prior to applying for an importer or wholesaler license with the Health Sciences Authority of Singapore (HSA).
SS 620 specifies the requirements for distributors and importers to implement a quality management system that focuses on ensuring the safety, quality and performance of medical devices throughout the distribution process.
Benefits of SS 620:2016 (2021) Certification
Enhance customer confidence
Maintenance of medical device quality throughout the distribution network .
Compliance to regulatory requirements
for import and wholesale license.
Improved company’s branding.
Increase productivity and efficiency
with an effective quality management system.
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Why get certified with SOCOTEC Certification Singapore?
SOCOTEC Certification Singapore is accredited by Singapore Accreditation Council (SAC) for SS 620:20216 (2021) for all activities and scope of medical devices, and we are able to assist with the upgrading from SS 620:2016 (2021) to ISO 13485:2016 Quality Management System for Medical Devices.
SS 620 Certification process: Step-by-step guide to getting certified
Pre-assessment audit
We can provide an independent audit of your management system before the commencement of the Stage 1 audit. (optional)
Stage 1 audit
First, we gain an understanding of your business to assess whether your document policy, objectives, continual improvement plans and procedures meet the requirements of the management system (MS) standard.
The readiness of your implementation programme is also assessed
Stage 2 audit
We will then audit your MS in action, to check that your declared policy, objectives and targets have been effectively communicated, and that your continual improvement plans and procedures are working in practice.
Certification is then awarded after successful closures of any outstanding issues.
Surveillance audit
After you have achieved certification, we undertake regular ongoing audits of your MS to ensure that it is being maintained and that it continues to meet the objectives of your organisation and the expectation of your customers.
Re-certification audit
The certificate is valid for 3 years.
A recertification audit is conducted on the full MS before the expiry of the certificate.
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Frequently asked questions about SS 620 certification in Singapore
Typically 4-8 weeks from initial application to certificate issuance, assuming your QMS documentation is ready.
Organizations starting from scratch may need 2-3 months for system implementation
Costs vary based on organization size (number of sites, employees), scope of medical devices (complexity, risk class), current QMS maturity.
Yes. SOCOTEC Certification Singapore offers an integrated audit approach where we assess both standards simultaneously, reducing audit time and costs.
Many importers upgrade to ISO 13485 to access international markets.
No. SS 620 is a Singapore-specific standard.
For international recognition, consider ISO 13485 or country-specific GDP certifications (e.g., EU GDP guidelines).
- Minor non-conformities can be corrected within 30 days.
- Major non-conformities require system improvements and a follow-up audit before certification issuance.
Yes. HSA requires SS 620 certification for all medical device classes (A, B, C, D) involved in import or wholesale activities.
Annually. SOCOTEC Certification Singapore conducts half-day surveillance audits to ensure ongoing compliance.
Certification is valid for 3 years with successful annual reviews.
HSS 620 certification is mandatory in Singapore because the Health Sciences Authority (HSA) requires it to issue or renew Importer's and Wholesaler's Licences for Class B, C, and D medical devices, ensuring patient safety and full traceability throughout the distribution chain.
- Medical device importers
- Wholesale distributors
- Third-Party logistics providers
Internal Auditor Training
SS 620 Training course
Good Distribution Practice for Medical Devices (GDPMDS) is a mandatory requirement established by HSA for companies involved in the handling, storage, delivery, installation, servicing, secondary assembly, and other related activities involving medical devices.
Whether you are a member of management, a Quality Manager or Executive, an internal auditor, or an SS 620:2016 implementer, this training course is designed for you.
Good Distribution Practice for Medical Devices (GDPMDS) is a mandatory requirement established by HSA for companies involved in the handling, storage, delivery, installation, servicing, secondary assembly, and other related activities involving medical devices.
Whether you are a member of management, a Quality Manager or Executive, an internal auditor, or an SS 620:2016 implementer, this training course is designed for you.
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