Medical equipment on the list announced by the Minister of Health of Vietnam must be tested for safety and technical features before being put into use (except for cases where inspection is exempt), periodically, after major repairs. So how will the medical equipment not meet the inspection requirements be handled?
Article table of contents
How to handle medical equipment that does not meet inspection requirements in Vietnam? (Illustration)
** In case the medical equipment fails to pass the test results before being put into use in Vietnam:
- Medical facilities are not allowed to receive and use medical equipment;
- The accrediting organization sends a written notice of the failed inspection results to the Ministry of Health of Vietnam;
- In case there are 03 medical devices in the same batch with unsatisfactory test results in terms of safety and performance, The Ministry of Health has requested in writing the owners of circulation registration numbers to report the quantity of medical equipment being circulated on the market and being used at medical facilities.
Based on the owner's report and the unsatisfactory test results, the Ministry of Health of Vietnam shall decide on the re-inspection, the number of samples to be re-inspected or suspend the use of the medical equipment.
Based on the results of re-inspection, the Ministry of Health of Vietnam will decide to continue re-inspection, supplement the number of samples subject to re-inspection or request the owners of the registration number to withdraw all medical equipment in that lot.
In case there are 03 batches of medical equipment that are recalled within the validity period of the free-sale registration number, the free-sale registration number shall be revoked for such medical equipment. Medical equipment that has been used at medical facilities before the time of the decision to revoke the free-sale registration number will continue to be used if the test results are satisfactory.
** In the case of medical equipment with results of periodic inspection, inspection after major repair fails in Vietnam:
- Medical facilities are not allowed to continue using medical equipment;
- Remove the old inspection status indication;
- Coordinating with the circulation number owner in taking remedial measures and performing re-inspection;
- Equipment can only be used when there are satisfactory test results.
Exemption from the first inspection before being put into use for medical equipment in one of the following cases:
1. Medical equipment that has a certificate of conformity.
2. Medical equipment without a free-sale registration number imported for the purpose of scientific research or training in the use, maintenance and repair of medical equipment.
3. Medical equipment without a free-sale registration number is imported to be used for personal treatment of the importer or for humanitarian medical examination or treatment or for special diagnostic needs.
4. Medical equipment without free-sale registration number imported to serve activities of fairs, exhibitions, display and product introduction.
Bao Ngoc
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