MEIKO Clean Solutions (SEA) Sdn Bhd, 8, Lorong Teknologi C (OMNI)
Taman Sains Selangor 1, Kota Damansara, 47810 Petaling Jaya, Malaysia
Telephone +60 3 6151 5461, Telefax +60 3 6151 5464, E-Mail: firstname.lastname@example.org
MEIKO medical devices are subject to this set of rules and regulations. They are assigned to risk class IIa in the product category 10-334.
MEIKO medical devices are monitored by the notified body CE0408 TÜV Austria
We comply with and implement the conditions stipulated in DIN EN ISO 13485:ff during the manufacture of MEIKO medical devices. The requirements specified in this standard go far beyond the general requirements of DIN EN ISO 9001:2008. In concert with DIN EN ISO 9001:2008, the EN ISO 13485:2012 standard defines the periodically reviewed MEIKO Quality Management System for medical devices. EN ISO 13485:2012 also describes the Good Manufacturing Practice (GMP) guidelines which we apply to the manufacturing of MEIKO medical devices.
Certification of the MEIKO QM system to ISO 13485:2012 is accredited by the Canadian organisation CMDCAS. This accreditation is a prerequisite for registering MEIKO medical devices with Health Canada (HC). Together with the licence from HC, this accreditation allows MEIKO medical devices to be exported to Canada. Adherence to the Medical Device Regulations (MDR) is a requirement for obtaining this accreditation.
Export of MEIKO medical devices to countries outside Europe is subject to a variety of different rules and regulations which are defined in the specific Medical Device Regulations (MDRs) for each country. The European conformity assessment process which MEIKO uses is only recognised by the authorities in target countries in a limited number of cases.
As a rule, MEIKO products, MEIKO as a manufacturer, and MEIKO's representative in the respective country must all be specifically registered with the authorities in the target country concerned. The granting of a national licence is generally associated with special product-specific documentation which MEIKO can provide. Over the years MEIKO has acquired numerous national licences which have been made possible thanks to collaboration between the MEIKO quality management team and the design and sales departments.