Medical Devices Act Article 82

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.