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.

Decoding the Classification of Medical Devices

Regulatory controls are intended to protect and safeguard the health and safety of patients. These controls were meant to ensure that manufacturers of medical devices adhere to specified procedures the product realization process which consist of designing, manufacturing and marketing. The higher degree of risk will result in more stringent regulatory control, taking account of the benefits offered by use of the device. Therefore, there will a necessity to classify medical devices based on their risk to patients, users and other persons.

The risk presented by a particular device depends substantially on its intended purpose and the effectiveness of the risk management techniques applied during design, manufacture and use. The risk presented by a device also depends, in part, on its intended user, its mode of operation, and/or technologies. In general, the classification rules are intended to accommodate new technologies.

The Classification of IVD Medical Device is based on the following criteria the intended use of the device as specified by the manufacturer the importance of the information to the diagnosis the impact of the result (true or false) to the individual and/or to public health.
Kindly refer to figure 1