1. An overview of the medical device, its intended use or purpose, and labeling; 2. Product specifications; 3. Specifications or procedures for manufacturing ...

Applications for the inspection of the medical device quality management system in accordance with Paragraph 2, Article 22 of this Act, shall be filed to the ...

Taiwan GMP is mandatory for all medical device manufacturers who want to sell their products in Taiwan, while 13485:2016 is voluntary.

Medical device manufacturers seeking access to the Taiwan market must first have their devices registered by the Taiwan Food and Drug Administration (TFDA).

The QSD is a critical component of the Regulatory framework for medical devices in Taiwan, ensuring that products meet the necessary quality and safety ...

Asia Actual helps manage the Taiwan Medical Device Registration process through the complex regulatory and registration process.

Taiwan Medical Device Quality Management System Regulation is effective on May 1st, 2021. ... The Medical Devices Regulations require class II, III and IV medical ...

The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013.

ISO 13485:2016, the most updated international standard of medical device quality management system. This standard had been recognized by global regulatory ...

15 янв. 2024 г. · For entry into the Taiwan market, all medical devices require pre-market approval. Manufacturers must register their products with the TFDA.