Category: Taiwan

The “Medical Devices Act” has come into effect from May 01, 2021. This act was announced on January 15, 2020 under the Presidential Decree. Taiwan Food and Drug Administration (TFDA) has amended the Pharmaceutical Affairs Act and stipulated a new law specifically for the management of medical devices. More information is available here.

The new “Medical Devices Act” is set to come into effect on May 01, 2021. This law was announced on January 15, 2020. Earlier medical devices were regulated by the Pharmaceutical Affairs Act, but now they will be part of the Medical Devices Act. Details about clinical trials on medical devices are included in Chapter IV, Article 37-39.

Medical device clinical trials conducted in Taiwan need prior approval from the Taiwan FDA. Sponsors will need to report any serious or life-threatening adverse events related to medical device clinical trials conducted in Taiwan. Even though the regulation includes a generic term called ‘information disclosure’, it has not been elaborated further.

Applications for participating in TCP III is still being accepted

June 30, 2020: Application for participating in the Technical Cooperation Programme, Version 3.0 (TCP III) on exchange of medical device quality management system(QMS) regulation and ISO 13485 audit reports is still being accepted.

The submission of application for participating in the Technical cooperation Programme (TCP) on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports between EU MDR/IVDR Notified Body Partners and R.O.C. Taiwan Food and Drug Administration (TFDA) Authorized Medical Device QMS Auditing Organizations, Version 3.0 (Known as TCP III) was open since 21st November, 2019.

Any notified body designated under EU MDR/IVDR is interested to participate in the TCP III, a submission of application for participating in TCP III is still welcome.

Overview of Taiwan’s regulatory system

As per the provisions under the Taiwan’s Pharmaceutical Affairs Act, a pre-market approval of medical devices is necessary prior to market entry in Taiwan. A Quality System Documentation (QSD) registration for the manufacturing facility is required in addition to medical device registration (exempted for Class I [non-sterile] medical devices) that meets Taiwan’s good manufacturing practice (GMP) requirements.

What is TCP?

In order to streamline the product registration process for medical devices that have received prior EU approval, the Republic of China (R.O.C.) Taiwan Food and Drug Administration (TFDA) Authorized Medical Device GMP Auditing Organizations and EU Medical Device Regulation(MDR)/ In-vitro Diagnostic Regulation (IVDR) Notified Body Partners have entered into a Technical Cooperation Program (TCP). It enables independent third-party organizations partnered with TCP to issue ISO 13485 certificate and audit report to TFDA on behalf of the  medical device manufacturers (located in EU) thereby replacing the requirement to submit QMS and easing the medical device registration process in Taiwan.

The first stage of assessment process including its qualifications and quality management system review is in progress. All applicants need to go through the second stage assessment (including on-site auditing and witness audits) before successfully becoming a partner of TCPIII. An EU MDR/IVDR Notified Body could successfully become a partner of TCP III once the assessment was completed and get the agreement signed.

Technical Cooperation Programme, Version 2.0 (TCP II) remains valid until 2021

May 14, 2020: Technical Cooperation Programme, Version 2.0 (TCP II) on exchange of medical device quality management system regulation and ISO 13485 audit reports remain valid until 2021.

Owing to COVID-19 situation, the on-site auditing and witness audits are waiting for arrangements based on overseas travelling constraints.

Currently, the Technical Cooperation Programme on Exchange of Medical Device GMP and ISO 13485 Audit Reports between EU AIMD/MDD/IVDD Notified Body Partners and R.O.C. TFDA Authorized Medical Device GMP Auditing Organization, Version 2.0 (Known as TCP II) remains valid.

In response to the forthcoming regulations on Taiwan Medical Devices Act and new application date for the new European Medical Device Regulation (MDR) announced by EC, the TCP II is expected to upgrade to TCP III by 25 May 2021.

Overview of Taiwan’s regulatory system

As per the provisions under the Taiwan’s Pharmaceutical Affairs Act, a pre-market approval of medical devices is necessary prior to market entry in Taiwan. A Quality System Documentation (QSD) registration for the manufacturing facility is required in addition to medical device registration (exempted for Class I [non-sterile] medical devices) that meets Taiwan’s good manufacturing practice (GMP) requirements.

What is TCP?

In order to streamline the product registration process for medical devices that have received prior EU approval, the Republic of China (R.O.C.) Taiwan Food and Drug Administration (TFDA) Authorized Medical Device GMP Auditing Organizations and EU Medical Device Regulation(MDR)/ In-vitro Diagnostic Regulation (IVDR) Notified Body Partners have entered into a Technical Cooperation Program (TCP). It enables independent third-party organizations partnered with TCP to issue ISO 13485 certificate and audit report to TFDA on behalf of the  medical device manufacturers (located in EU) thereby replacing the requirement to submit QMS and easing the medical device registration process in Taiwan.

The first stage of assessment process including its qualifications and quality management system review is in progress. All applicants need to go through the second stage assessment (including on-site auditing and witness audits) before successfully becoming a partner of TCPIII. An EU MDR/IVDR Notified Body could successfully become a partner of TCP III once the assessment was completed and get the agreement signed.