Taiwan technical cooperation program (TCP)
UL is a partner in the bilateral Technical Cooperation Program between the European Union, Switzerland and Chinese Taipei. This partnership means that UL Notified Body and ISO 13485 Registration customers can use their UL issued certificates towards gaining legal market entry to Taiwan. Access to Taiwan is just another example of how UL sets the standard in global regulatory services.
Overview
The Department of Health (DoH) of Chinese Taipei has established legislative requirements for medical devices (including IVDDs) that must be met before such devices can gain legal market entry. For devices manufactured overseas and exported to Chinese Taipei, the importer of the product located in Chinese Taipei has responsibility for the marketing and approval of the product. The importer should send a marketing application for the product including technical information to the DoH. The DoH will then conduct a technical evaluation of the information provided and will appoint a third-party Designated Auditing Organization (DAO) to assess the Good Manufacturing Practice part of the regulations.
The appointed DAO will assess the quality management system of the importer. As part of this evaluation the manufacturing site of the subject device will require to be assessed as part of the overall evaluation of the GMP regulations. If the manufacturing site of the device is located in the European Union or Switzerland, the DAO can use QMS certificates issued by TCP Partners such as UL as evidence of meeting the GMP regulations.
Qualification requirements
The following eligibility criteria is verified prior to acceptance of an application by a manufacturer for this program:
- Geo-political coverage -- The program is restricted to manufacturers (factory sites) located within the 27 member states of the European Union and Switzerland.
- Device Definition -- All devices falling under the scope of the MDD or IVDD are eligible for this program. This includes such devices that may be Class 1 under the MDD or IVDs that do not require a Notified Body.
The UL advantage
- Current certificates issued by UL Notified Body under Annex II or V for under the MDD or Annex IV certificates under the IVDD are eligible for this program and will be accepted by the DAO as evidence of compliance with Taiwan GMP regulations.
- When the device is exempt from Notified Body regulation, Quality Management (ISO 13485) Certificates issued by UL and certified by UL are also accepted.
