Paragraph 15.1
Applicants who apply for a permit or a registration for filing and reference for the use of radioactive material or equipment capable of producing ionizing radiation shall possess one of the following qualifications:
1.a government agency (or organization);
2.a post-secondary high (or vocational) school or academic research organization;
3.a company or other legal person;
4.a medical institution, radiology center or medical laboratory established with the official approval of the public health competent authority;
5.a veterinarian medical institution officially established in accordance with the Law Governing Veterinarian; or
6.other qualifications as approved by the Competent Authority.
Paragraph 15.2
In the case of an application for the use referred to in Paragraph 15.1, the applicants shall meet the following criteria:
1.having qualified operating personnel;
2.possessing a workplace or storage area meeting radiation safety regulations; and
3.other criteria as designated by the Competent Authority.

Paragraph 16.1
For use of the following radioactive material, a registration application shall be made to the Competent Authority for filing and reference:
1.sealed radioactive material of Category IV and Category V as listed in Table I;
2.radioactive material that forms a component of an instrument or manufactured product and that has an activity less than 1,000 times that of the exemption level and that under normal usage has a surface dose rate at an accessible distance of 5 cm of less than 5 micro-sieverts (μ Sv) per hour;
3.radioactive material besides those mentioned in Subparagraphs 16.1.1 and 16.1.2 with an activity less than 100 times that of the exemption level; or
4.other radioactive material as designated by the Competent Authority.
Paragraph 16.2
For use of radioactive material other than those stipulated in Paragraph 16.1, an application for a permit shall be made to the Competent Authority.

• Table I：Categories of Sealed Radioactive Material.PDF

Paragraph 17.1
For use of the following equipment capable of producing ionizing radiation, applicants shall apply for a registration to the Competent Authority for filing and reference:
1.nominal voltage is less than 150 kV or particle energy is less than 150 keV;
2.cabinet or baggage inspection X-ray machine, ion implanter, electron beam welding machine or static eliminator that under normal usage has a surface dose rate at an accessible distance of 5 cm of less than 5 micro-sieverts (μ Sv) per hour; or
3.other equipment as designated by the Competent Authority.
Paragraph 17.2
For use of equipment capable of producing ionizing radiation other than those stipulated in Paragraph 17.1 or for non-medical use of those stipulated in Subparagraph 17.1.1 with direct irradiation on human bodies, an application for a permit shall be made to the Competent Authority.

Paragraph 18.1
Applicants for use of sealed radioactive material or equipment capable of producing ionizing radiation for which a permission application shall be made shall, when applying for import or transfer, fill out an application form, enclose the following documents and make an application to the Competent Authority for review. In cases that shield engineering is involved in the installation, the installation permission will be granted after review and approval; in cases that shield engineering is not involved in the installation, following the grant of permission by the Competent Authority for import or transfer, the documents referred to in Paragraph 18.2 shall be enclosed to the Competent Authority for review, inspection and approval, after which the permit for use will be issued:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (or organizations);
2.photocopies of the relevant operating personnel credentials and the certificates of employment;
3.workplace radiation safety assessment. In cases that shield engineering is not involved, a shielding planning need not to be enclosed;
4.a radiation protection plan and radiation safety operation guidelines;
5.photocopies of the certificates of radiation protection personnel shall be submitted in conformity with the stipulations in the Standards for Establishment of Radiation Protection Management Organizations and Radiation Protection Personnel; and
6.for use of sealed radioactive material of Category I and Category II as listed in Table I, a security planning shall be submitted.
Paragraph 18.2
Only after the applicants referred to in Paragraph 18.1 have obtained the installation permission can installation begin in accordance with the officially approved workplace radiation safety assessment, the floor plans and the shielding planning. Within 30 days after completion of the installation, the following documents are to be enclosed to the Competent Authority for review, inspection and approval, after which the permit for use will be issued:
1.a radiation safety survey report (hereinafter referred to as "survey report");
2.for sealed radioactive material conforming with the stipulations referred to in Paragraph 54.1, a sealed radioactive material smear test report shall be submitted (hereinafter referred to as "smear test report"); and
3.for sealed radioactive material, a photocopy of the original certifying document of radioactive material shall be submitted.

• Table I：Categories of Sealed Radioactive Material.PDF

Paragraph 19.1
For unsealed radioactive material or re-packaged and labeled radioactive material whose use requires a permission, applicants shall fill out an application form, enclose the following documents and make an application to the Competent Authority for review and approval, after which the installation permission will be granted:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (or organizations);
2.photocopies of the relevant operating personnel credentials and the certificates of employment;
3.workplace radiation safety assessment;
4.a radiation protection plan and radiation safety operation guidelines;
5.for the labeling of radioactive material, information on the physical and chemical properties of the radioactive material as well as on the handling process used shall be submitted; and
6.in conformity with the stipulations in the Standards for Establishment of Radiation Protection Management Organizations and Radiation Protection Personnel, photocopies of the certificates of radiation protection personnel shall be submitted.
Paragraph 19.2
Only after the applicants referred to in Paragraph 19.1 have obtained the installation permission can the shield engineering installation begin in accordance with the officially approved workplace radiation safety assessment. Within 30 days after completion of the installation, a radiation safety survey report is to be enclosed to the Competent Authority for review, inspection and approval, after which the permit for use will be issued.

The workplace radiation safety assessments referred to in Subparagraph 18.1.3 and Subparagraph 19.1.3 shall deliberate the following items for appropriate assessing, in accordance with the scale and nature of the radiation practice:
1.workplace floor plans and shielding planning;
2.measures for handling radioactive contaminants;
3.protective measures on mobile radioactive material or equipment capable of producing ionizing radiation; and
4.personnel dose assessment.

The permit for use is effective for a maximum period of five (5) years. Facility operators shall fill out an application form 60 to 30 days before the expiration date and enclose the following documents to the Competent Authority for review, inspection and approval, after which renewal of the permit for use will be issued:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (or organizations);
2.the original permit for use;
3.a survey report done within the last 30 days; and
4.for sealed radioactive materials conforming with the stipulations referred to in Paragraph 54.1, the latest smear test report shall also be enclosed.

Paragraph 22.1
Facility operators who have obtained the permit for use of radioactive material or equipment capable of producing ionizing radiation shall fill out an application form before making modifications and enclose the following documents to the Competent Authority for review and approval, after which the modification permission will be granted:
1.workplace radiation safety assessment in accordance with the stipulations of Article 20.;
2.photocopies of the relevant operating personnel credentials; and
3.the original permit for use.
Paragraph 22.2
In cases where the modification referred to in Paragraph 22.1 involves a change in radiation safety, a radiation protection plan or radiation safety operating guidelines shall be enclosed.
Paragraph 22.3
Only after the facility operator obtains the modification permission may the modification proceed in accordance with the approved workplace radiation safety assessment. Within 30 days after completion of the modification, the following documents shall be enclosed to the Competent Authority for review, inspection and approval, after which the permit for use will be issued:
1.a survey report; and
2.for sealed radioactive material in conformity with the stipulations referred to in Paragraph 54.1, a smear test report shall be submitted.

Paragraph 23.1
For use of sealed radioactive material that the use requires a registration for filing and reference approved by the Competent Authority, applicants shall, when applying for import or transfer, fill out an application form, enclose the following documents and make an application to the Competent Authority for review. If shield engineering is involved in the installation, the installation permission will be granted after review and pproval; if shield engineering is not involved in the installation, after the Competent Authority grants the permission of import or transfer, the documents referred to in Paragraph 23.2 are to be enclosed to the Competent Authority for review and approval, after which the registration will be approved:
1.photocopy of the certification of establishment or the registration approved; waived for government agencies (or organizations);
2.photocopies of the relevant operating personnel credentials and the certificates of employment;
3.workplace floor plans and shielding planning; the shielding planning may be waived if shield engineering is not involved or Subparagraph 16.1.2 is qualified; and
4.a radiation protection plan.
Paragraph 23.2
Only after the applicants referred to in Paragraph 23.1 have obtained the modification permission may the modification proceed in accordance with the approved workplace floor plans and shielding planning. Within 30 days after completion of the modification, the following documents shall be enclosed to the Competent Authority for review and approval, after which the registration will be approved:
1.a photocopy of the original radioactive material certification;
2.a survey report; and
3.for sealed radioactive material in conformity with the stipulations referred to in Paragraph 54.1, a smear test report shall be submitted.
Paragraph 23.3
For use of equipment capable of producing ionizing radiation that the use requires a registration for filing and reference approved by the Competent Authority, applicants shall fill out an application form, enclose the following documents and make an application to the Competent Authority for review prior to the use of the equipment, after which a registration will be approved:
1.name and number of the certification of establishment or the registration approved;
2.name and number of the relevant operating personnel credentials;
3.survey report related information; and
4.a radiation protection plan.

For unsealed radioactive material or re-packaged, labeled radioactive material, whose use requires a registration, applicants shall fill out an application form, enclose the following documents and make an application to the Competent Authority for review and approval, after which a registration will be approved:
1.photocopy of the certification of establishment or the registration approved; waived for government agencies (or organizations);
2.photocopy of the relevant operating personnel credentials and the certificate of employment;
3.workplace floor plans and shielding planning;
4.a radiation protection plan; and
5.for the labeling of radioactive material, information on the physical and chemical properties of the radioactive material as well as on the handling process used shall be submitted.

Once every five (5) years, the facility operators who have the registration approved by the Competent Authority for radioactive material or equipment capable of producing ionizing radiation three (3) months prior to or after the month equivalent to the approved registration month, shall conduct a radiation safety survey and record the results for future reference.

Paragraph 26.1
When the radioactive material for which the registration has been permitted is to be modified, the facility operators shall fill out an application form before modification and enclose the following documents to the Competent Authority for review and approval, after which a modification permit will be issued:
1.workplace floor plans and shielding planning; and
2.photocopy of the relevant operating personnel credentials.
Paragraph 26.2
Only after the facility operators have obtained the modification permit may the modification work proceed in accordance with the approved workplace floor plans and shielding planning. Within 30 days after the work is completed, the following documents shall be enclosed to the Competent Authority for review, after which a registration will be approved:
1.survey report; and
2.for sealed radioactive material in conformity with the stipulations referred to in Paragraph 54.1, a smear test report shall be submitted.
Paragraph 26.3
The facility operators who have the registration approved by the Competent Authority for equipment capable of producing ionizing radiation shall, within 30 days after the modification work is completed, fill out an application form and the following information, enclosed to the Competent Authority for review and approval, after which a registration will be approved:
1.name and number of the relevant operating personnel credentials.
2.survey report related information and radiation detection data.
Paragraph 26.4
If, after modification, the energy level of the equipment capable of producing ionizing radiation or the total activity of the radioactive material reaches the level stipulated that the certificate of permission shall be applied for, then matters shall proceed in accordance with the stipulations referred to in Article 22.

Paragraph 27.1
For radioactive material or equipment capable of producing ionizing radiation, if there will be a movement to a new location or a change of the workplace and therefore an installation or modification is involved, the facility operators shall fill out an application form and apply for a certificate of permission for use or a registration for filing and reference separately in accordance with the installation or modification stipulations referred to in Article 18, Article 22 and Article 23.
Paragraph 27.2
If the facility operators, who have obtained the certificate of permission or the registration approved by the Competent Authority for the use of unsealed radioactive material, will increase the number of workplaces, the number of nuclides or activity used, they shall apply for a certificate of permission for use or a registration for filing and reference separately in accordance with the stipulations referred to in Article 19 and Article 24.

Paragraph 28.1
For use of a high-level radiation facility, applicants shall fill out an application form and enclose the following documents to the Competent Authority for review and approval, after which a permit for installation will be issued:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (or organizations);
2.workplace radiation safety assessment;
3.radiation protection plan and radiation safety operation guidelines;
4.the structure of workplace shielding and machinery and an earthquake enduring level certification;
5.operational training and practical operational training plan;
6.schedule plan of a trial operation run;
7.for sealed radioactive material, a photocopy of the original radioactive material certification and security planning shall be enclosed; and
8.procedure for dealing with accidents.
Paragraph 28.2
The workplace radiation safety assessment referred to in Subparagraph 28.1.2 shall contain the following information:
1.workplace floor plans and shielding planning;
2.facility radiation dose assessment and protection measures;
3.measures for handling radioactive contaminants (including activated products); and
4.other information as designated by the Competent Authority.
Paragraph 28.3
Only after the applicants have obtained the permit for installation may the work proceed in accordance with the approved radiation safety assessment, the floor plans, and the shielding planning. Within 30 days after completion of the work, a trial operation run plan shall be enclosed to the Competent Authority for review, inspection and approval, after which a trial operation run permit will be issued.
Paragraph 28.4
After the completion of the trial operation run, the applicants shall enclose, within 30 days, a trial operation run report to the Competent Authority for review, inspection and approval, after which a certificate of permission for use will be issued.
Paragraph 28.5
The trial operation run report referred to in Paragraph 28.4
shall include the following items:
1.the area monitoring results;
2.the personal dose monitoring results;
3.the record of the trial operation run; and
4.other items as designated by the Competent Authority.

The certificate of permission for use of a high-level radiation facility is effective for a maximum period of five (5) years. The facility operators shall fill out an application form 60 to 30 days before the expiration date and enclose the following documents to the Competent Authority for review, inspection and approval, after which a renewed certificate of permission for use will be issued:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (or organizations); and
2.the survey report done within the last 30 days.

For installation or modification of radioactive material or equipment capable of producing ionizing radiation, the work shall be completed within the time frames as specified below. If the work is not completed within the specified time frame, an application for extension may be made to the Competent Authority one (1) month prior to the deadline:
1.a high-level radiation facility shall be completed within two (2) years of the approved installation or modification date.
2.work involving the use of radioactive material or equipment capable of producing ionizing radiation to which the permit shall be applied, other than that referred to in Article 30.1, shall be completed within one (1) year of the approved installation or modification date.
3.work involving the use of equipment capable of producing ionizing radiation to which the registration for filing and reference is to be applied shall be completed within one (1) year of the approved import or transfer date.

Paragraph 31.1
Those who are engaged in radiation protection service businesses shall not possess radioactive material. However, the following circumstances with the permission of the Competent Authority are excluded:
1.those who sale sealed radioactive material referred to in Paragraph 16.1;
2.those who are engaged in sales service businesses or radiation protection detection businesses replace sealed radioactive material for facility operators and do temporary storage of the material before export or transfer; or
3. those who are engaged in sales service businesses or radiation protection detection businesses do temporary storage of unsealed radioactive material during transportation.
Paragraph 31.2
Applicants who apply for possession of radioactive material according to the stipulations in Subparagraphs 31.1.1, 31.1.2 and 31.1.3 shall fill out an application form, enclose the following documents and make an application to the Competent Authority for review, inspection and approval, after which a possession permit will be issued:
1.the permit of radiation protection service businesses;
2.application documentation on the brand, model, nuclide, activity and quantity of the radioactive material for possession;
3.radiation protection plan; and
4.radiation safety assessment on an appropriate storage area and shielding planning. They shall be finished according to the maximum holding of the radioactive material estimated for the appropriate storage area.
Paragraph 31.3
Those who are permitted by the Competent Authority to engage in the sales of equipment capable of producing ionizing radiation may possess the equipment capable of producing ionizing radiation according to the approved items.

Paragraph 32.1
For any of the following situations, the applicants shall apply for a possession permit:
1.inability to complete the installation or the modification within the time frame stipulated in Article 30;
2.subsequent to the approval by the Competent Authority for import or transfer, inability to proceed the installation following the delivery; or
3.other situations as approved by the Competent Authority.
Paragraph 32.2
The applicants shall, 30 days prior to the deadline stipulated in Article 30 or within 30 days from the delivery of the radioactive material or the equipment capable of producing ionizing radiation, enclose the following documents and make an application to the Competent Authority for review. After the equipment capable of producing ionizing radiation is reviewed and approved, a possession permit will be issued; after the radioactive material is reviewed, inspected and approved, a possession permit will be issued:
1.reasons for possession;
2.radiation protection plan;
3.the storage area. For radioactive material, the floor plans and the shielding planning shall be submitted; and
4.for sealed radioactive material in conformity with the stipulations of Paragraph 54.1, a smear test report shall be submitted.
Paragraph 32.3
The possession permit referred to in Paragraph 32.2 is effective for a maximum of two (2) years.
Paragraph 32.4
The facility operator may, within 60 to 30 days prior to the expiration of the possession permit of the radioactive material or the equipment capable of producing ionizing radiation, fill out an application form and enclose all the documents provided in Paragraph 32.2 to the Competent Authority for extension, which is subject to a maximum of one (1) time.

Paragraph 33.1
For the certificate of permission for radioactive material or equipment capable of producing ionizing radiation or the designated items in the registration approved by the Competent Authority, if there is change of the printed items or loss or damage of the certificate of permission, the facility operator shall, within 30 days of the occurrence, fill out an application form and apply to the Competent Authority for change, reissue or renewal.
Paragraph 33.2
The period of effectiveness for the permit is the same as that for the original one.

Paragraph 34.1
When a facility operator replaces the X-ray tube or the accelerator tube of equipment capable of producing ionizing radiation, he/she shall proceed according to the following stipulations. However, the following stipulations are not applicable to the replacement of the X-ray tube of static eliminators:
1.for that who obtains the permit for use, a survey report shall be enclosed to the Competent Authority for filing and reference within 15 days after the replacement.
2.for the registration approved by the Competent Authority, the survey report shall be independently kept.
Paragraph 34.2
If a facility operator removes and replaces radioactive material for which he/she possesses the permit for use or the registration approved by the Competent Authority, he/she shall fill out an application form and enclose the following documents prior to effecting the replacement, and submit to the Competent Authority for review; and within 30 days following the replacement, he/she shall enclose a smear test report and a photocopy of the original certifying documentation of the newly installed radioactive material to the Competent Authority for filing and reference:
1.the documents relating to the transport details; and
2.method of processing the original radioactive material after the replacement.
Paragraph 34.3
For the replacement of radioactive material provided in Paragraph 34.2, if the container is replaced at the same time, the application shall be filed in accordance with the stipulations set forth in Article 18 and Article 23 before the replacement.