For the manufacture and import of medical devices, an application shall be filed with the central competent authority for registration and market approval. No manufacture or import shall be allowed until such approval is granted and a medical device license is issued. However, the manufacture and import of product items announced by the central competent authority shall be done by means of listing.
Medical devices that shall apply for registration and market approval in accordance with the preceding paragraph shall not do so by means of listing.
The import of medical devices shall be done by license holders, those who have completed the listing, or their authorized persons.
If the medical device that shall be listed in accordance with the exception of Paragraph 1 has obtained medical device license approval before this Act becomes effective, the central competent authority shall complete the listing directly, cancel the original license, and notify the original license holder.

Alteration may only be made to any of the particulars of registration and market approval or listing pertaining to any medical device designated by the central competent authority after approval of the central competent authority is obtained.

A medical device manufacture or import license is valid for a period no longer than five years starting from the date of issue. Where it is necessary to continue the manufacture or import upon expiration, a prior application shall be filed with the central competent authority for approval of license extension. Each extension shall not exceed five years. For those who fail to file an application upon the expiration period or if the extension is disapproved, the original license shall become invalid and be cancelled by the central competent authority.
In case the license set forth in the preceding paragraph can no longer be used due to stain or damage, an application shall be submitted along with the original license to the central competent authority for replacement. In case of loss, an application for re-issuance shall be filed.

Medical device firms that have completed the listing of medical devices shall file an annual declaration with the central competent authority each year. For those who fail to file a declaration within the time period, the original listing shall become invalid. This shall also apply to the medical devices subject to direct listing as stipulated in the provisions of Paragraph 4 of Article 25.

Regulations governing the following related matters shall be established by the central competent authority:
1. Requirements, procedures, and review guidelines in regard to the application for registration and market approval and issuance of license or listing of medical devices in accordance with the provisions of Article 25.
2. Requirements and procedures in regard to the application for alteration of the particulars of registration and market approval or listing in accordance with the provisions of Article 26.
3. Procedures in regard to the application for extension, replacement, and re-issuance of licenses in accordance with the provisions of Article 27.
4. Procedures in regard to the annual declaration in accordance with the provisions of the preceding article.

Medical device product items designated by the central competent authority shall comply with specific specifications and performance.
The product items, specifications, test methods, and performance of medical devices referred to in the preceding paragraph shall be announced by the central competent authority. If a test method has not been established, an internationally recognized method may be adopted; if there is no internationally recognized test method, the suitability thereof shall be demonstrated.

The central competent authority, with regard to data submitted by medical device firms for registration and market approval or listing that are information related to trade secret or business operation, shall restrict them from being made available to the public or provision. However, this shall not apply to information that is necessary for the public benefit or protection of the health of human body.

Medical device firms that manufacture or import medical devices shall attach labels in Chinese to the smallest packaging unit for sale and provide Chinese instructions before engaging in the sale, wholesale, and retail. However, this shall not apply to those announced or approved by the central competent authority due to the difficulty in compliance.

Medical device firms shall indicate the following particulars on the labels, instructions, or packaging of medical devices, as approved, registered and approved, or listed in accordance with Paragraph 2 of Article 13 and Paragraph 1 of Article 25. However, this shall not apply to those exempt from such indication as announced by the central competent authority:
1. Product name.
2. License number or listing number.
3. Effectiveness, intended use, or indications.
4. Date of manufacture and period of validity or shelf-life.
5. Model number, specifications, or major components.
6. Warnings, cautions, use limitations, or expected and foreseeable side effects.
7. Name and address of the license holder or the person who completed the listing.
8. Name and address of the manufacturer.
9. Lot number or serial number.
10. Other particulars that shall be indicated as announced by the central competent authority.
For specific medical devices announced by the central competent authority, the instructions set forth in the preceding paragraph may be replaced by electronic instructions.
In addition to the indication specified in the first paragraph, medical devices that are necessary to provide braille characters or other sufficient information for ease of reading as a supplementary measure shall be announced by the central competent authority.

Manufacturers exporting domestically manufactured medical devices to foreign countries may apply to the central competent authority for certificates required by the countries where such medical devices are to be exported.
Medical devices set forth in the preceding paragraph may be restricted for export when the central competent authority deems that there is a concern of insufficiency to meet domestic demand.
Medical devices that are approved to be manufactured for export only shall not be sold domestically. However, this shall not apply when the central competent authority deems that there is a concern over domestic demand.
Medical device firms holding licenses of necessary medical devices announced by the central competent authority shall, in the case of incapable to continue to manufacture, import, or the likelihood of insufficient supply of said medical devices, report to the central competent authority at least six months in advance; and shall, if unable to report within the aforementioned period due to natural disaster or other incidents not attributable to the medical device firms, report to the central competent authority within 30 days after occurrence of such incidents.
The central competent authority may, upon receiving the report set forth in the preceding paragraph or becoming aware of the likelihood of insufficient supply of necessary medical devices, register it on a public website.

The central competent authority may grant special approval for manufacture or import of specific medical devices without the limitations set forth in Paragraph 1 of Article 25 if any of the following circumstances applies:
1. For the purpose of preventing, diagnosing, or treating life-threatening or severe disability diseases, with appropriate alternative treatment not yet available domestically.
2. The necessity of responding to emergency public health circumstances.
3. Investigational medical devices.
4. For the exclusive use as samples or gifts, or for personal use.
5. Where the import thereof is for the exclusive purpose of repair, and not for circulation or sale domestically after the repair is completed.
6. Where circumstances exist for incapable to continue with the manufacture, import, or for insufficient supply of licensed products that have been announced as necessary medical devices in accordance with Paragraph 4 of the preceding paragraph.
Regulations governing the application requirements, review procedures, approval criteria, restrictions on supply and sale, return, and other matters to be complied with in regard to the special approval referred to in the preceding paragraph shall be established by the central competent authority.

If any of the following circumstances applies to the medical devices for which special approval for manufacture or import has been obtained as set forth in the preceding article, the central competent authority may cancel their approval and order the applicant to take action on or recall the said medical devices within a time period:
1. An appropriate alternative treatment becomes available.
2. The public health emergency situation is over.
3. There is concern about the safety or therapeutic effect as evaluated and confirmed by the central competent authority.