ISO 13485 / GDPMDS / SS 620:2016 - Quality Management For Medical Devices
Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 13485 is the worldwide Quality Management System (QMS) standard for medical device organizations. ISO 13485 potentially beneficial for medical device organizations as it:
- Enhances the organization’s ability to meet customers and regulatory requirements
- Helps organizations to address product safety and effectiveness
- Allows organizations to obtain external recognition of conformity to quality management system
Recently, the standard has been revised by the
International Organization for Standardization (ISO) to ISO 13485:2016 which
was published on 1st March 2016. With the revision, ISO has issued out a
three-year transition period, therefore, as of 28th February 2019,
ISO 13485:2003 shall cease.
What are the main changes of ISO 13485:2016?
- New design specification based on ISO Guide 72
- Harmonization with US CFR, Brazilian law (ANVISA), CMDR (Canada), and other law
- The standard has integrated risk throughout the quality management system, and product life-cycle, risk-based decision-making has been incorporated
- Emphasis on documentation for regulatory purposes
- Integration with QMS software
- Emphasis on appropriate infrastructure
- New references to other standards have been included for usability, sterile barrier, etc
- New sections on complaint handling and reporting to regulatory authorities
- Clarity for auditing
- Planning and documenting corrective action and preventive action
However, ISO 13485:2016 has maintained its current format (based on ISO 9001:2008).
SCS has obtained accreditation from the Singapore Accreditation Council (SAC).
Good Distribution Practice for Medical Devices (GDPMDS - TS-01, Revision 2.1 / SS 620:2016)
In Singapore, companies that are involved in the import, storage, distribution, installation, servicing and secondary assembly of medical devices are required to pass Good Distribution Practice for Medical Devices (GDPMDS) certification audit prior to applying for Importer or Wholesaler’s License.
- Customer confidence - Medical device quality is maintained throughout the distribution network
- Regulation compliance for Import and Wholesale license application
- Positive image of the company
As of 9 May 2017, the standard was recently revised to SS 620:2016 - GDPMDS by SPRING Singapore in collaboration with Singapore Manufacturing Federation - Standards Development Organization (SMF-SDO), and the Health Sciences Authority (HSA). The stipulated transition period for SS 620:2016 is three years from 9 November 2017 - 8 November 2020.