Requirements Medical Devices Manufacturers in Singapore By Siew En

Medical Devices Manufacturers in Singapore are required to be certified to ISO13485 standard prior to applying for a Manufacturer’s license from the Health Sciences Authority.Companies that are involved in distribution or importing Medical Devices in Singapore are required to obtain the GDPMDS certificate prior to applying for Importer or Wholesaler’s License.

In order to be certified by the certification body, companies are required to have implemented a quality management system that adheres to current good distribution practices. Medical devices companies are required to implement quality management system, procedures and with suitable facility and transportation to handle, store and transport the medical devices in accordance to current Good Manufacturing or Distribution Practice of Medical Devices.

Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, Transported and handled under suitable condition as required by the marketing authorization or product specification.Companies who are currently certified to ISO 9001:2008 will find that they have partially fulfilled the GDPMDS requirements.

However there are differences between ISO 9001:2008 and GDPMDS or ISO13485:2003 which companies will need to reconcile before going for certification. To provide with assurance, companies will require quality manuals, comprehensive system to give assurance via proper procedures, qualified personnel, correct processes/ facilities /equipment.

Singapore’s Health Sciences Authority (HSA) released new guidelines on the preparation of a Site Master File (SMF) for pharmaceutical Good Distribution Practice (GDP) certification.