The competent authority may send officials to inspect the facilities and relevant business operations of medical device firms or medical institutions, and may randomly test their medical devices. Those being inspected shall not evade, impede, or refuse. The quantity of test samples to be taken shall be limited to the extent sufficient for use in testing, and receipts shall be given to business operators.

Medical device product items designated by the central competent authority shall only be released after passing random inspections or tests at the time of import.
Regulations governing the product items and the items, modes, methods, scope, fees for random inspection and testing of medical devices referred to in the preceding paragraph, and other related matters shall be established by the central competent authority.

The municipal or county (city) competent authority shall conduct a census of medical device firms at least every two years, to which the medical device firms shall not evade, impede, or refuse.

If the central competent authority finds that a medical device is likely to cause serious harm to the health of human body, it shall immediately prohibit its manufacture or import, and may cancel its medical device license or listing. As for such medical device that has been manufactured or imported, its export, sale, supply, transport, storage, brokerage, transfer, or display with the intent to sell shall be prohibited for a time period. Such medical device may be confiscated and destroyed if necessary.

Regarding medical devices suspected to have not been registered and approved or listed or to be defective medical devices, for medical devices that have not been registered and approved or listed, the municipal or county (city) competent authority shall first place them in confinement at the site and take samples for inspection or testing before taking further actions. For defective medical devices, the authority may first place them in confinement at the site and take samples for inspection or testing before taking further actions. As for those which have caused serious harm, they shall be confiscated and destroyed after reporting for approval to the central competent authority.
The quantity of the samples set forth in the preceding paragraph shall be limited to the extent sufficient for use in inspection or testing, and receipts shall be given to business operators.
For medical devices set forth in Paragraph 1, the competent authority may notify or announce the withdrawal, cessation of use, or suspension of the manufacture, import, or sale thereof.

In the case of any defective medical device or medical device that has not been registered and approved or listed, the following measures shall be undertaken according to the circumstances in addition to the actions to be taken under applicable provisions of this Act:
1. For those that manufacture or import medical devices that have not been registered and approved or listed or that use the licenses of others, the original approving authority may cancel all or part of their medical device licenses or listings, medical device business permits, medical device manufacturing licenses, or registered particulars regarding the company, business, or factory.
2. For those that sell or display with the intent to sell medical devices that have not been registered and approved or listed, a sales ban shall be imposed. In the case of repeated violation, their business operations may be suspended.
3. For those that manufacture, import, sell, or display with the intent to sell defective medical devices, in the case of a serious violation or repeated violation, the original approving authority may cancel all of their medical device licenses or listings and medical device manufacturing licenses, or may suspend their business operations.
The competent authority may announce the name, address, and responsible person of firm or business subject to the disciplinary actions set forth in the preceding paragraph, name of medical devices, and circumstances of violation.

In case the defective medical devices seized are domestically manufactured and may, after inspection or testing, still be usable through modification, the municipal or county (city) competent authority shall assign officials to supervise the original manufacturer in carrying out the modification within a time period. Those that cannot be modified or are not modified within the time period shall be confiscated and destroyed. Imported defective medical devices shall be immediately placed in confinement, and the municipal or county (city) competent authority shall order the original importer to return and export such devices within a time period. Those which are not returned within the time period shall be confiscated and destroyed.
In case any defective medical device set forth in Subparagraph 6 of Article 8 is seized, the municipal or county (city) competent authority shall order the medical device firm that manufactures or imports the device to correct its quality management system within a time period according to the severity of its circumstances.
The provisions of Paragraph 1 shall apply mutatis mutandis to medical devices that have been determined to be manufactured or imported without registration and market approval or listing.

If any of the following circumstances is found to apply to any medical device, the medical device manufacturing or importing firm shall immediately notify medical institutions, other medical device firms, and pharmacies, and shall recall and handle marketed and stocked products within the specified time period:
1. Where a license has been obtained or listing has been completed, but its manufacture or import is prohibited by announcement.
2. Where the medical device is defective or has not been registered and approved or listed.
3. Where the finding after inspection, testing, or other risk assessment is that there is likelihood to cause harm to the health of human body for users.
4. Where the medical device manufacturing license has been cancelled by the central competent authority, or the medical device is manufactured or imported during the period when the medical device manufacturing license is not valid.
5. Where the manufacture or import of medical devices violates the provisions of Articles 26, 32, or 33.
6. Other circumstances in which a necessary recall is announced by the central competent authority.
When the medical device manufacturing or importing firm recalls medical device of the preceding paragraph, medical institutions, other medical device firms, and pharmacies shall give their cooperation.
Regulations governing the classification, approaches for recall operation, handling methods, and other matters to be complied with in regard to medical devices required to be recalled of Paragraph 1, shall be established by the central competent authority.

The competent authority shall not only strictly keep confidential the identity information of those reporting defective medical devices that have been seized or medical devices that have not been registered and approved or listed, but also provide them incentives at its discretion.