Streamlining the Registration Process for Medical Devices

Taiwan is one of the few countries in the world that still requires the submission of either a “Free Sale Certificate” (FSC) or “Certificate to Foreign Government” (CFG) as a component of the registration process for medical devices. The FSC proves that certain commodities, such as food items, cosmetics, or medical devices are legally sold and distributed in the open market and authorized by regulatory authorities from the exporting country. The CFG confirms that a medical device has been cleared and authorized for sale in the United States specifically.

In most countries, the CFG and FSC are no longer required. This is due to the fact that most manufactures today are involved in cross-national production, and often engage only in the manufacturing process and do not market products in the country of origin. As a result, these countries are unable to provide a FSC/CFG certificate when applying for a new registration or applying to extend existing licenses.

In their position paper in the American Chamber of Commerce in Taipei’s recently published 2017 Taiwan White Paper, the Chamber’s Medical Devices committee recommends gradual removal of the FSC/CFG requirements. Information in the FSC/CFG about the manufacturing facility and the products used for specific medical devices can now be found from other sources, such as the product label, the instructions-for-use booklet, and the original Letter of Authorization. In addition, the committee notes that the Good Manufacturing Practice (GMP) system for medical device manufacturers has been in effect for over ten years. Both domestic and international manufacturers must fulfill the GMP requirements to assure that their products are of high quality and do not pose any risk to consumers. By following the requirements set out by the GMP system, Taiwan’s medical device manufacturers adhere to international quality-control standards. Removal of the FSC/CFG would align Taiwan with global trends in medical device laws and regulations and help reduce the pre-market registration time for medical devices.

In seeking to further reduce registration time, the committee recommends simplifying the renewal requirements for Quality System Documentation (QSD). QSD is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Under current renewal requirements, QSD must be renewed every three years and the renewal procedure is the same as the initial QSD application.

The Committee also recommends the disclosure of more information about the review process for proposed additions and revisions in medical service procedures. “Such disclosure would not only be in line with the spirit of the Second Generation National Health Insurance (NHI), but would also help the public to better understand NHI policy direction and participate appropriately,” the Committee notes in its position paper.

To read the full Medical Devices position paper, click here.

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