In the event of changes in any of the items enumerated under Subparagraphs 1 to 3 of Paragraph 1 of Article 8, the testing institution shall, within the following periods, submit an application for changes to the central competent health authority:
1. Change of laboratory address: application shall be filed within 30 days of event.
2. Change of the basis of testing methods: application shall be filed within 90 days of event.
3. Change of test scope due to amendments of the dosage limitation of abnormal substance contained in Chinese medicine and Concentrated Chinese Medicinal Preparations: application shall be filed within 90 days of the effective date.
4. Change of the title of the testing institution, the title of the laboratory, the name of the laboratory head or the report signatory: application shall be filed within 90 days of event.
For the applications specified above, the central competent health authority, when necessary, may conduct on-site review.

Relocation based on the Subparagraph 1 of Paragraph 1 of the preceding Article shall be reported to the central competent health authority in a relocation plan 15 days prior to the relocation.
The plan mentioned in the preceding paragraph shall include the following items:
1. The time course of relocation.
2. The laboratory's new address and location map.
3. The test instrument list and the test facility configuration diagram.

Upon failure to perform the test as specified in the accreditation, the exclusive laboratory of the testing institution shall notify the central competent health authority of the event within seven days from the date of the event; and the same applies when the function is resumed.

A testing institution shall perform testing based on the quality manual as specified in Item (1) in Subparagraph 3 of Article 4 and the standard operating procedures for methods of testing as specified in Item (2) and shall comply with the following provisions:
1. Sign a written contract of test entrustment with the client when entrusted with a test, indicating the entrusted test items, test methods, test scope, status of accreditation of the entrusted test items, and other matters. For any changes to the entrustment, the content of and the reasons for the changes shall be stated in the contract of test entrustment and verified and recorded by both parties.
2. Accurately record the detailed information of the client and the use purpose of the test report.
3. Accurately record the condition of sample(s) received, including the name, batch number, manufacturing date or expiry date, source, packaging, and quantity of the sample(s). No space or column shall be left blank; moreover, photographs of the sample(s) submitted for testing shall be kept on file.
4. The test report shall indicate the sample information, test item, testing method, test scope, and test results. All information shall be true and accurate.
5. Make clear statements or remarks where the report also contains results beyond the scope of accreditation (including test item, testing method, and test scope)
6. Non-accredited testing methods shall not be used for performing tests on accredited test items; however, this limitation shall not apply where such is requested in a specifically signed contract with the client or in a written request of the client, and such is specified in the test report.
7. The test report shall clearly note the following: "The test report merely reflects the test results of the consigned matters of the client and is not a certification of the legitimacy of the related products."
8. The test report and records of quality control information and raw data shall be kept on file together for at least 3 years.
9. Test reports shall be designed to thwart forgery.
10. The entrusted matter shall not be sub-entrusted to another person without the consent of the client; in the case where consent is granted to sub-entrust the matter to another person, the other person shall be one that possesses the ability to perform the entrusted test items, and the test report shall include the serial number of the test report issued by the sub-entrusted organization or other traceable information.
11. Products of different names, raw material sources, or samples in minimum individual packages shall be tested separately and covered in separated test reports, with no mixture.
12. The results of all the entrusted test items of the same sample listed in the test entrustment contract shall be stated in the same test report.
13. For tests performed on accredited test items, the results shall be stated in a test report in the form recognized by the central competent health authority.

The central competent health authority shall regularly audit the equipment, personnel organization, quality management, operating procedures, testing capacity, and test records of the accredited testing institutions and may require the testing institutions to submit reports of the testing procedures conducted within the accreditation scope. When necessary, the central competent health authority may conduct irregular audit.
The central competent health authority may require the testing institutions to take, at their own expenses, proficiency testing activities organized by the central competent health authority, or administered by other proficiency testing providers as entrusted or recognized by the central competent health authority.
Testing institutions are not entitled to evade, obstruct, or refuse the audit procedure, report submission, and proficiency testing participation requirement prescribed in the foregoing two paragraphs.

Where the testing institution undergoing the proficiency testing required in the second paragraph of the preceding article fails to pass the proficiency assessment, it shall be obliged to institute corrective actions within 15 days following the date of acceptance of the test assessment notice; moreover, a corrective action report shall be submitted to the central competent health authority. The testing institution shall be required to receive the follow-up proficiency testing as per date scheduled by the central competent health authority.

When a major unforeseen drugs event happened, testing institutions receiving an emergency mobilization notification from the central competent health authority shall be obliged to process the drugs testing within the prescribed deadline; thereafter, testing institutions shall submit complete sample information and testing results to the central competent health authority.

In any of the following circumstances of a testing institution, the central competent health authority may suspend or abolish its accreditation. Where the accreditation is abolished, the testing institution is not allowed to apply for accreditation within one year:
1. Violation of the provisions of Paragraph 3 of Article 14 of no evading, obstructing, or refusing.
2. False information contained in test statistics, test reports or other documents and information submitted.
3. Other violations of the provisions of this set of regulations causing the central competent health authority to deem the testing institution unsuitable for test administration.

In any of the following circumstances of a testing institution, the central competent health authority may suspend or abolish a part or all of the accredited test items:
1. After obtaining the accreditation according to this set of Regulations, the exclusive laboratory no longer exists or the laboratory does not meet the conditions set out in Article 3.
2. Violation of the provisions of Article 10, with no changes made or no changes made within the time limit.
3. Violation of the provisions of Article 11 or Article 12, with no report or notification submitted within the time limit.
4. Violation of the provisions of any one paragraph of Article 13.
5. Violation of the provisions of Article 15, by failing to submit a corrective action report within the time limit, failing to take the follow-up proficiency test, or failing to pass the test.
6. Closedown or discontinuation of the testing institution.