The enforcing authority may collect the necessary fees incurred by confiscation and destruction under this Act from offenders.

Fees shall be paid when a person applies for or declares permits, licenses, or other matters in accordance with this Act, or makes formal inquiry about product registration and market approval, listing, annual declaration, and relevant regulations of medical devices.
Standards for the type and amount of the fees required in the preceding paragraph shall be determined by the central competent authority.

When necessary, the competent authority at any level may designate a subordinate agency or commission a relevant agency (or institution), legal entity, organization, or private institution to conduct all or part of the testing of medical devices. Regulations governing its designation, commissioning, and related matters thereof shall be established by the central competent authority.

The central competent authority may carry out accreditation of the relevant agency (or institution), legal entity, organization, or private institution commissioned to conduct testing, as set forth in the preceding article. Regulations governing their accreditation and management shall be established by the central competent authority.
The central competent authority may designate a subordinate agency or commission another agency (or institution), legal entity, organization, or private institution to carry out the accreditation work as set forth in the preceding paragraph. Regulations governing its designation, commissioning, and related matters thereof shall be established by the central competent authority.

The central competent authority may designate a subordinate agency (or institution) or commission another agency (or institution), or an accredited legal entity or organization to carry out education and training of technicians, review of registration and market approval of medical devices, issuance of certificates, review and inspection of clinical trials, review of advertisements, reporting of serious adverse events, and inspection or census of medical device firms.
With the exception of education and training, the commissioned agency shall observe avoidance of conflicts of interest for matters related to designation or commissioning set forth in the preceding paragraph. Regulations governing its commissioning, accreditation, avoidance of conflicts of interest, and other related matters shall be established by the central competent authority.
The central competent authority may designate a subordinate agency or commission another agency (or institution) to carry out the accreditation work as set forth in Paragraph 1. Regulations governing its designation, commissioning, and related matters shall be established by the central competent authority.

The central competent authority and central industry competent authority may provide incentives for research and development of innovative medical device technologies.
Regulations governing the eligibility criteria, review procedures of the incentives referred to in the preceding paragraph, and other related matters may be jointly established by the central competent authority and central industry competent authority.

Due to the characteristics for use of medical devices, when research institutions, medical institutions, or medical device firms collect, process, or use personal data in accordance with Subparagraph 6 of Paragraph 1 of Article 6 of the Personal Data Protection Act, the central competent authority may announce other methods of consent equivalent to the written consent.

In the event of violating the provisions set forth in Paragraph 1 or 2 of Article 8 and consequently resulting in occurrence of damages arising from injury to the medical device end-user patients or consumers, medical device manufacturers or importers shall be liable for compensation. However, this shall not apply if the medical device manufacturers or importers have no negligence in regard to the manufacturing, packaging, labeling, sterilization, or final inspection and release of the medical devices, or the injury is not caused by the negligence, or has exercised reasonable care to prevent such injury from occurring.
Even if the medical device end-user patients or consumers under the circumstances of the preceding paragraph have suffered an injury that is a non-pecuniary damage, they may claim for a reasonable amount of monetary compensation.
For claims filed by the medical device end-user patients or consumers set forth in the preceding two paragraphs, provisions of Articles 47 through 55 of the Consumer Protection Act may apply mutatis mutandis for initiation of consumer litigation.
Under the circumstances identified in Paragraph 1 or 2, if it is difficult or impossible for the medical device end-user patients or consumers to prove the monetary value of the actual damage, they may ask the court to award the compensation in the amount of at least NT$1,000 per incident, per person based on the severity of the damage.
In the event that the municipal governments or the county/city governments receive multiple claims from 20 or more medical device end-user patients or consumers due to the same incident, they shall assist medical device end-user patients or consumers to bring litigation in accordance with the provisions of Article 50 of the Consumer Protection Act.

Starting from the effective date of this Act, the provisions of this Act shall apply to the management of medical devices, and the provisions of the Pharmaceutical Affairs Act governing medical devices shall no longer be applicable.

The Enforcement Rules of this Act shall be established by the central competent authority.

The date for enforcing this Act shall be determined by the Executive Yuan.