Ss 620 - Good Distribution Practice For Medical Devices (gdpmds) Transition_10.02.2017 736l55

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-a4b07515a7467ae8.

What are the changes to SS 620:2016? There are several changes to the standard in 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 1 2 3 4 5 6 7 8 9 10 11 12 13 14

GDPMDS TS-01 Revision 2.1 Introduction Quality Management System Resource Management Storage and Stock Handling Traceability Medical Device Complaints Field Safety Corrective (FSCA) Return of Medical Devices Disposal of Medical Devices Counterfeit, Adulterated, Unwholesome or Tampered Medical Devices Internal Audit Management Review Outsourced Activities Secondary Assembly

SS 620:2016 Scope Normative References and Definitions Quality Management System Management Responsibility Resource Management Premises and Facilities Secondary Assembly Traceability Counterfeit, Adulterated, Unwholesome or Tampered Medical Devices Complaint Handling Field Safety Corrective Action (FSCA) Internal Audit Outsourced Activities

2. Definition and Terminology SPRING Singapore and its collaborators, SMF-SDO and HSA has enhanced the definition of certain 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 . 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 First run of SS 620:2016 Internal Auditor Course

8 Nov 2020 9 Nov 2017

Expiry of GDPMDS – TS-01 Rev 2.1

Implementation of SS 620:2016

9 May 2017

2018

Official publication of SS 620:2016

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

2019

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 Ms. Salwa Halid either via phone at 6299 9001 or via email at [email protected].