SS 620:2016 – Good

Distribution Practice for Medical

Devices – Requirements
 The Health Sciences Authority (HSA) has mandated that companies involved in wholesale
and/or importing of medical devices in Singapore to obtain GDPMDS certification (TS-01: Good
Distribution Practice for Medical Devices, Revision 2.1).

Recently, SPRING Singapore has collaborated with Singapore Manufacturing Federation –

Standards Development Organization (SMF-SDO) and HSA to revise existing GDPMDS
requirements to SS 620:2016 – Good Distribution Practice for Medical Devices – Requirements
under the Singapore Standardization Programme. The new standard can now be purchased at:
https://www.singaporestandardseshop.sg/Product/Product.aspx?ID=cf789d94-5aec-44f8-a4b0-
7515a7467ae8.

What are the changes to SS 620:2016?

There are several changes to the standard in terms of the following:

1. Framework

To streamline and standardized the standards as part of Singapore Standardization Programme,

SPRING Singapore has reorganized the clauses in the standard to ensure orderly progression
of the management system.

Clause GDPMDS TS-01 Revision 2.1 SS 620:2016

1 Introduction Scope
2 Quality Management System Normative References
3 Resource Management Terms and Definitions
4 Storage and Stock Handling Quality Management System
5 Traceability Management Responsibility
6 Medical Device Complaints Resource Management
7 Field Safety Corrective (FSCA) Premises and Facilities
8 Return of Medical Devices Secondary Assembly
9 Disposal of Medical Devices Traceability
Counterfeit, Adulterated, Unwholesome Counterfeit, Adulterated, Unwholesome
10
or Tampered Medical Devices or Tampered Medical Devices
11 Internal Audit Complaint Handling
12 Management Review Field Safety Corrective Action (FSCA)
13 Outsourced Activities Internal Audit
14 Secondary Assembly Outsourced Activities

2. Definition and Terminology

SPRING Singapore and its collaborators, SMF-SDO and HSA has enhanced the definition of
certain terms to create a better understanding of the Good Distribution Practice for Medical
Devices requirements.

Aside to that, there has been slight change in the terminology for certain clauses, with the
removal and/ or addition of certain terms. Therefore, these changes will affect companies to a
certain extent. It is advisable for companies certified to GDPMDS – TS-01 Rev 2.1 to understand
the new standard requirements and embark on the transition process as soon as possible from
its effective implementation date 9 November 2017.
 Transition Period

The relevant agencies have stipulated the effective implementation of SS 620:2016 –

Good Distribution Practice for Medical Devices – Requirements from 9 November 2017 until
8 November 2020. Therefore, companies certified to GDPMDS – TS-01 Rev 2.1 are given three
years to transit to SS 620:2016. Please refer to below for the transition timeline:

16 - 17 July 2017 8 Nov 2020

9 Nov 2017
First run of SS Expiry of
620:2016 Internal Implementation of GDPMDS – TS-01
Auditor Course SS 620:2016 Rev 2.1

9 May 2017 2018 2019

Official
publication of
SS 620:2016

27 July 2017
First run of
SS 620:2016
Transition
Workshop (½ day)
Frequently Asked Questions (FAQs)

1. How soon can I start the transition process?

It is advantageous to start conveying internally early as the standard has been officially published
on 9 May 2017. Therefore, you may wish to review your Site Master File and existing GDPMDS
procedures to determine if they are in line with SS 620:2016 structure and requirements.

2. How long will GDPMDS – TS-01, Revision 2.1 continue to be recognized and audited to?

The current GDPMDS – TS-01 Revision 2.1 will be recognized and can be audited until the end
of the three-year transition period (8 November 2020).

Nonetheless, to ensure completion of transition to SS 620, certification starting from

1 September 2019 should be based on SS 620:2016.

3. When should I transit?

Companies may opt to transit either during surveillance or recertification audit.

4. What are the available training for SS 620:2016?

For delegates trained to GDPMDS – TS-01 Rev 2.1, they are required to attend a ½ day transition
workshop on SS 620:2016 requirements. The delegates would be briefed on the changes
accordingly.
However, if the delegates have yet to acquire any knowledge on GDPMDS – TS-01 Rev 2.1, it
is advisable for them to attend the 2-days SS 620:2016 Awareness & Internal Auditor Course.

For more information on our workshops and courses, please feel free to contact Ms. Salwa Halid
either via phone at 6299 9001 or via email at salwa.halid@socotec.com.