January 10, 2020

The Taiwan Council passed the draft of the " Regulations of Medical Devices" (hereafter simply referred to as the “Regulation”) in December 2019. The regulation has medical devices to be legislated independently and thus no longer fall under the Pharmaceutical Affairs Act.

The Regulation will further formulate a management mechanism in accordance with the product life cycle and the principle of risk management. In addition, to cooperate with the government on the promotion of the "Biomedical Industry Innovation Promotion Plan", the Regulation focuses on the development of the academic, research communities and the industry (maintenance industry) to enhance the industry's international competitiveness.

The main differences between the Regulation and the Pharmaceutical Affairs Act are as follows:

1. Incorporate medical device design and maintenance operators into the special law, while manufacturing, importing and maintenance operators must hire technical staff.

2. Establish an online registration system for low-risk medical devices.

3. Introduce a flexible mechanism for the validity of medical device licenses.

4. Regulations will also be included in the management of clinical trials of medical devices.

5. Develop open methods in response to the identified emerging sales patterns (vending machines).

6. Standardize the establishment of the unique device identification system (UDI) to store and track information on medical devices.

7. An excellent transportation and marketing system must be established to ensure product quality and to standardize the medical equipment transportation and marketing management system.

8. Medical institutions should assist in cooperating with the implementation of the post-market surveillance system, and medical device distributors shall actively monitor product safety.

9. A medical device supplier holding a medical device license, which is announced by the central authority as a necessary medical device, shall be required to report in case it is unable to continue manufacturing, importing or adequately supply the product.

10. The medical device advertising period has been extended from one year to three years.

11. Medical devices that are restricted to be used by medical staff can now be advertised in a wider scope. Although remaining inaccessible to the general public, content concerning these devices can be published via specific communication tools, such as medical journals, forums, or other channels dedicated to medical personnel.

Qualtech’s suggestions:

1.      Manufacturers or their distributors need to hire or assign qualified technicians.

2.      Manufacturers or their distributors need to establish and comply with the UDI regulations.

3.      The medical device distributors need to obtain GDP certification issued by TFDA.


The Regulation of Medical Device

Taiwan FDA, Regulation, UDI, GDP