Regulations Governing Designation or Commission of Medical Devices Test
2021-04-30
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Article 1
These regulations are promulgated pursuant to the authority of Article 77 of the Medical Devices Act.
Article 2
The competent authority at any level may designate a subordinate agency or commission a relevant agency (or institution), legal entity, organization, or private institution to conduct all or part of the testing of medical devices.
The designation in the previous paragraph refers to the following: for competent authority at the central level, the Ministry of Health and Welfare, Food and Drug Administration as well as other subordinate agencies (or institutions); at the local level, agencies (or institutions) designated by the competent authorities of the municipality, county (or city); all associated rights and obligations are specified by the designated agency.
The designation in the previous paragraph refers to the following: for competent authority at the central level, the Ministry of Health and Welfare, Food and Drug Administration as well as other subordinate agencies (or institutions); at the local level, agencies (or institutions) designated by the competent authorities of the municipality, county (or city); all associated rights and obligations are specified by the designated agency.
Article 3
The commissioned agency (or institutions), legal entity or organization in the preceding Article shall fulfill the following criteria:
1. Possessed with test abilities of test items, related place, facilities and equipments.
2. Established test operation process and quality assurance plan.
1. Possessed with test abilities of test items, related place, facilities and equipments.
2. Established test operation process and quality assurance plan.
Article 4
The delegator and commissioned agency shall put in place a contract agreement; the content of such agreement should include the following:
1. Commissioned items.
2. Commissioned schedule.
3. The rights and mechanisms to supervision and auditing by the Delegator.
4. Obligation of commissioned agency to keep confidentiality of personal information and trade secrets that became known or possessed by the commissioned agency, during its implementation of the contract items.
5. The requirement for contract rescission and termination.
6. Obligations of commissioned agency after contract rescission and termination.
7. Mechanisms to deal with contract disputes.
8. Other items of rights and obligations.
1. Commissioned items.
2. Commissioned schedule.
3. The rights and mechanisms to supervision and auditing by the Delegator.
4. Obligation of commissioned agency to keep confidentiality of personal information and trade secrets that became known or possessed by the commissioned agency, during its implementation of the contract items.
5. The requirement for contract rescission and termination.
6. Obligations of commissioned agency after contract rescission and termination.
7. Mechanisms to deal with contract disputes.
8. Other items of rights and obligations.
Article 5
The commissioned agency shall provide a receipt and obligated to secure and store the specimen when receiving medical device specimens for contract testing,.
The commissioned agency shall provide a test analysis report to the delegator after the test is completed; the test result may be sent prior through electronic transmission according to the request of the delegator if necessary.
The commissioned agency shall provide a test analysis report to the delegator after the test is completed; the test result may be sent prior through electronic transmission according to the request of the delegator if necessary.
Article 6
The test report under the second paragraph of the preceding Article shall indicate the following requirements:
1. Test report number and other identifiable information
2. Name, address, telephone number and related information of the commissioned agency.
3. Name, address and number of the commission test sheet of the delegator.
4. Name or code of the medical device specimen, exterior appearance or physical characteristics description and photograph, date of receiving, enforcement date of test, test method, test results and assigned related items of the contract.
5. Brand, model number, serial number or batch number, manufacturer, license number, manufacturing date, expiry period or storage period and other information of the medical device specimen.
6. Date of the analysis report and signature or stamp of the analysis report signatory or responsible person.
1. Test report number and other identifiable information
2. Name, address, telephone number and related information of the commissioned agency.
3. Name, address and number of the commission test sheet of the delegator.
4. Name or code of the medical device specimen, exterior appearance or physical characteristics description and photograph, date of receiving, enforcement date of test, test method, test results and assigned related items of the contract.
5. Brand, model number, serial number or batch number, manufacturer, license number, manufacturing date, expiry period or storage period and other information of the medical device specimen.
6. Date of the analysis report and signature or stamp of the analysis report signatory or responsible person.
Article 7
With consent of the delegator, the commissioned agency may commission a third party that fulfills the conditions outlined in Article 3 to handle technical items; the test report number provided by the third party or other traceable identity information must be included in the test report.
Article 8
The commissioned agency shall fulfill the obligation of confidentiality and are prohibited to disclose any information to public related to the commissioned items and test result.
Article 9
These regulations are enacted from May 1st of 2021.