HSA has expressed that they would be implementing a SAC Accreditation requirement on certification bodies who are issuing ISO 13485 for Singapore manufacturers tentatively in the year 2024.
Although this requirement is for the certification bodies, Singapore manufacturers should prepare for this transition eventually.
CMS MEDTECH has developed a set of questions that Singapore manufacturers should ask themselves and the follow up actions.
- Are you a medical device manufacturer in Singapore? This means you are performing manufacturing and you have a manufacturer dealer license from HSA. If yes please see point 2.
- Do you intend to continue to manufacture in the year 2024? If yes please see point 3.
- Do you use a self declaration letter to attain your Class A manufacturer license? If no, please see point 4.
- Do you use MDSAP to attain your manufacturer license? If no, please see point 5.
- Do you have a ISO 13485 certificate or you used your global HQ ISO 13485 certificate (multi-site cert) to attain your manufacturer license? Please see below.
- Does your ISO 13485 certificate contains the SAC accreditation? If no please see below.
- Does your certification body (or global certification body) intends to get themselves SAC accredited by year 2024? if yes, please ensure they provide the SAC cert before the transition period ended.
- If no it is time to get a new certification body! Or get MDSAP cert.
For more info please contact us here.
Table of Contents
Info from HSA
From: HSA MD Info (HSA) <HSA_MD_Info@hsa.gov.sg>
Sent: Tuesday, March 9, 2021
Cc: HSA MD Info (HSA) <HSA_MD_Info@hsa.gov.sg>
Subject: Webinar on ISO13485 certification in Singapore
Dear Industry Stakeholders,
The Medical Devices Branch (MDB) of HSA had organised a webinar on ISO13485 certification for medical device licensed dealers in Singapore on 2 March 2021. The webinar provided information on the accreditation of certification bodies (CBs) certifying local medical device dealers to ISO13485 for medical device regulatory purposes.
The presentation slides can be found on the HSA website: https://www.hsa.gov.sg/announcements/regulatory-updates/industry-briefing-(march-2021)
Please note that the slide on implementation plan has been updated (fonts in red) to accurately reflect the proposed timeline. Additionally, we have also added slides at the end of the presentation material, on key discussion points from the QnA session for your reference.
