Hospital and clinic patients as well as the public in Singapore can now be assured that the medical devices used to treat them are properly handled and distributed so that their integrity is not compromised. The Singapore Accreditation Council (SAC) recently launched the accreditation scheme for the certification of Good Distribution Practice for Medical Devices in Singapore (GDPMDS).

This scheme was introduced to support the Health Sciences Authority (HSA) of Singapore in implementing its Health Products Act 2007 which requires medical devices to be regulated according to the supply/distribution chain (manufacturer, importer and wholesaler), product registration and advertising and promotions.

Under the Health Products Act 2007, medical devices are the first product group to be regulated. The key areas of regulatory control include:

a) Supply/distribution chain (manufacturer, importer and wholesaler)
b) Product registration
c) Advertising and promotions

Some 2,000 importers and distributors must comply with the Good Distribution Practice for Medical Devices (GDPMDS) requirements from the second quarter of this year. A transition period of one and a half years has been given for importers and wholesalers of medium and high risk medical devices (such as lung ventilator) and two years for low risk medical devices (such as tongue depressors) to comply with the GDPMDS requirements and be licensed by the HSA.

The HSA only recognizes SAC-accredited GDPMDS certification of importers and wholesalers of medical devices with effect from the first quarter of this year.

Benefits of Accreditation
Besides supporting the HSA to implement its regulation, the scheme will provide third party assurance that certification bodies are competent in providing certification for GPDMDS. SAC accredited certification will in turn help to ensure the quality and integrity of medical devices throughout the distribution process.

Criteria for Accreditation
The SAC will accredit certification bodies to ISO/IEC Guide 62: 1996¹ and CT 04: 2008 SAC Criteria for Certification Bodies (Good Distribution Practice for Medical Devices in Singapore). The application form and related documents for the scheme are available on the SAC website at http://www.sac-accreditation.gov.sg/

Criteria for Certification
Certification bodies will certify organisations to the HSA Medical Device Technical Specification TS-01: Good Distribution Practice for Medical Devices in Singapore Requirements, a copy of which can be downloaded from the HSA website at http://www.hsa.gov.sg.

Application for Accreditation
Existing SAC accredited QMS certification bodies have to apply for an extension of scope to the existing QMS accreditation scheme. A timeframe of about six months would be required to conduct document review, office assessment and witnessed assessment. QMS certification bodies not accredited by SAC can also apply for accreditation.

For more information about this scheme, call the SAC on tel. (65) 6279 1855 / 1856 or e-mail: sac@spring.gov.sg. ET

¹ To be replaced by ISO/IEC 17021 after 15 September 2008