In the event the medicaments applied for inspection correspond to one of the following situations, the competent authority may require the obligatory inspection applicant to provide written documentation before a given date, to explain the reasons for non-conformance, and a proposed improvement plan with preventative measures:
1. Same product applied for batch-by-batch examination by the same obligatory examination applicant does not conform to regulations for the second time.
2. Products belong to the same origin of medicaments permit license, and whose inspection results do not conform to regulations for three times within 180 days.
3. Chinese medicine materials belonging to the same origin, same country and same commodity classification code of the Republic of China, and whose inspection results do not conform to regulations for three times within 180 days.

In the event the medicaments applied for inspection correspond to one of the following situations, the competent authority may temporarily suspend the application for inspection from the same manufacturer, same origin, or same country:
1. Products mentioned in the preceding article and the written documentations provided are not approved upon review.
2. Products mentioned in the preceding article requiring written documentations are not provided before the given date or the following imported products applied for inspection still do not conform to regulations by the given date.

The obligatory inspection applicant shall file an application to the inspection authority at the port where the medicaments are to be imported, 15 days prior to the date of inspection.
If the representative files the application, an identification document for the representative shall be provided. The representative shall submit a letter of Power of Attorney and shall register at the inspection authority.

The samples required for inspection shall be taken free-of-charge. The maximum number (amount) of sampling shall be limited to what is required for laboratory examination and sample retention purposes. After collecting the samples, the authority shall issue a receipt for sampling to customs officials and the obligatory inspection applicant.

Inspectors shall conduct random sampling at port. If samples are difficult to be sampled at the port, the inspection authority shall designate an alternative sampling location.
For the above mentioned sampling, the obligatory inspection applicant shall not designate the sample.

Examination shall be conducted in the order of sampling. However, the examination laboratory shall prioritize inspection on products applying for re-examination according to these regulations.

For inspection of medicaments, that are difficult to sample in a container yard, require five or more days for examination at the laboratory, perishable, or lack stability on safety efficacy, the inspection authority shall issue a Notice of Prior for Import for custom clearance after the obligatory inspection applicant declares to bear the responsibility for the safety and storage of products imported with an Affidavit. The inspection authority may issue a Notice of Prior Release for Import for customs clearance since the necessity of examination.
If the pledged storage location does not conform to the actual storage location, or medicaments are put to use before receiving the import permit, the inspection authority may temporarily suspend acceptance of an application for prior release of imports by the obligatory inspection applicant for a period of 180 days.

After medicaments applied for inspection are found to conform to the regulations, the inspection authority shall issue a medicaments import notification ,the obligatory inspection applicant can apply to the inspection authority for a notification of the medicaments import admitted.
The obligatory inspection applicant can claim remaining samples by presenting the sampling receipt within 15 days after receipt of the notice of inspection results. However, if the sample is not collected within the time period or has short shelf life, the inspection authority may dispose of the samples directly.

In the event the medicaments fail to conform to regulations, a notification of noncompliance for medicaments will be issued.
The obligatory inspection applicant can apply for re-examination to the original inspection authority within 15 days after receipt of the notification of results. Applications for re-examination is limited to one time only, and are performed by the original testing laboratory using remaining samples for the re-testing. For medical devices, if the remaining samples are not adequate for re-examination, additional sampling may be done according to Article 15.
Remaining samples of products that do not conform to regulations shall be destroyed after the end of the period of application for re-examination, unless otherwise stated by law.

For imported medicaments that do not conform to regulations upon inspection, unless otherwise stated by law, shall be shipped back or destroyed by the obligatory inspection applicant.
If imported products that have been released via a prior release notice do not conform to regulations mentioned in the preceding paragraph, the competent authority shall order the obligatory inspection applicant to retrieve the medicaments, and ship back or destroy the medicaments according to the preceding paragraph.