JAE2 Consultancy​

SS 620:2016 - Good Distribution Practice for Medical Device (GDPMD)

Effective Date: 08 November 2020 

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It is mandated by the Health Sciences Authority (HSA) in Singapore that all companies involved in wholesale and/or importation of medical devices must obtain GDPMDS certification. However, there has been a revision recently by SPRING Singapore, in collaboration with the Singapore Manufacturing Federation – Standards Development Organization (SMF-SDO) and HSA.​

The personnel responsible for QMS should start to revise their Site Master File and existing GDPMDS proceduresin accordance with the structure and requirements of the new standard. All companies currently certified to GDPMDA - TS-01 Rev 2.1 have three years to transit to SS 620:2016. The current standard will still be recognised and audited until 8 Nov 2020, In order to ensure a full transition to the new standard, certification starting from 1 Sep 2019 are advised to follow SS 620:2016.