North America
Europe
Denmark
France
Germany
Sweden
Switzerland
U.K.
Latin America
Asia Pacific
Argentina
Brazil
Mexico
Australia
China
Hong Kong
India
Japan
Korea
New Zealand
今まで以上に規模を拡大して内容を充実させたULのグローバル調査。製造者と消費者の態度や優先順位にどのような差異が見られるかを、様々な製品関連の検討要因にわたって精査します。

詳細を見る >
ULは、4つの基本分野全体にわたる基本的な発見、試験方法、ソフトウェア、規格を通して、世界をより安全にしていくための重要な方法を示す強力な取り組みであるNew Scienceをお届けしていることを誇りとしています。

詳細を見る >

規格

弊社の厳格な要件に基づいて、毎年何千点もの製品やコンポーネントに対する試験が行われています。

ダッシュボード

これまで以上にスマートで効率的かつ高速になったULのダッシュボードツールは、進化し続けるマーケットニーズを満たしていく企業のお役に立ちます。

詳細を見る >

ライブラリ

MARKS HUB

サービス

規格

Share

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.