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GMP Domestic Medical Device Manufacturing Management System


The Good Manufacturing Practice (GMP) system in Taiwan is a certification system based on international standards.The aim is to bring all medical devices under a comprehensive management system according to their use and hazard classification, and to recognise the quality of good domestic medical devices through a certification system, so as to enhance fair and healthy competition with imported products.

The Ministry of Health and Welfare of the Executive Yuan announced on 10 February 1999 that all factories must comply with the Good Manufacturing Practice (GMP) for medical devices as of 10 February 2004. The GMP system has been set up to help factories to strengthen the quality of their products and to align them with international standards, to strengthen their competitiveness and marketing capabilities, and to create real value.

Definition of medical devices by international organizations

The manufacturer's intended use is for instruments, equipment, software, materials or other similar or related items used for human beings, either alone or in combination, for one or more of the following specific purposes.These purposes are:

  • Diagnosis, prevention, monitoring, treatment or palliation of disease.
  • Diagnosis, guardianship, treatment, mitigation or compensation for injury.
  • The study, substitution, or regulation or support of anatomical or physiological processes.
  • To support or sustain life.
  • Pregnancy control.
  • Medical devices.
  • Medical information is provided through in vitro examination of samples taken from the human body.
  • The main designed effects on the body surface or in the body are not obtained by pharmacological, immunological or metabolic means, but may involve these means and play a complementary role.

Definition of medical devices by the Ministry of Health and Welfare in Taiwan

  • Active medical device: A medical device that uses electrical or other energy sources, not directly generated by people or gravity, to perform its functions.
  • Implantable active medical device: An active medical device that is implanted, in whole or in part, in the human body or in the body's natural cavity by medical or surgical means and is left in place continuously.
  • Implantable non-active medical device: A non-active medical device that is implanted, in whole or in part, by medical or surgical means into the human body or into the natural cavity of the human body, replacing the upper epidermis or the surface of the eye, and is retained in the human body for more than 30 days and can only be removed by medical or surgical means.
  • Explanatory Note: A notice issued by the manufacturer in accordance with the regulations of the central health authorities after the delivery of medical devices to provide additional information or recommend measures to be taken, including the use, correction, recall or destruction of medical devices.
  • Customer Complaint: A customer expresses dissatisfaction with the characteristics, quality, durability, reliability, safety or functionality of a listed medical device in writing, by telecommunication or verbally.
  • The Centre provides a complete and professional service for medical equipment products and components in accordance with international/national standards such as ISO, EN, BS, ANSI, ASTM, JIS, AS, CNS, etc. It is your best choice.

Systematic model

  • System planning stage - integration of international/national regulations, medical industry standards, customer requirements and the establishment of corporate organizational specifications and authority and responsibility structures.
  • System construction stage - Planning and construction of GMP domestic medical device manufacturing management system standard procedures, operation process and risk assessment management system (ISO14971).
  • System development stage - education and training, establishment and promotion of GMP domestic medical device manufacturing management and technical standards and records.
  • System implementation stage - internal audit and correction, management review and GMP domestic medical device manufacturing management system operation, correction and technical capability integration.
  • System validation phase - external audit validation service; including formal system validation registration and continuity assessment.

Head office, Taoyuan

Mr. Jason Chen