Common use of Application Review and Agreement Process Clause in Contracts

Application Review and Agreement Process. 1.1.1. Applications for product conformity and ISO 13485 assessment concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company shall fill in and sign the application forms completely. The documents required in the application form shall be delivered to SZUTEST along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. 1.1.2. SZUTEST shall initiate the application assessment process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST may consult to the Competent Authority during the process of application assessment. 1.1.3. SZUTEST may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company shall perform the financial obligations provided in the agreement and deliver all the documentation including specifically the Technical File, Design dossier and quality management system documentation to SZUTEST within maximum 10 business days. 1.1.7. As for transfer applications, SZUTEST may demand the company and the previous notified body to execute a transfer agreement with no financial value. 1.1.8. SZUTEST may contact the previous notified body or certification body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body or certification body, SZUTEST may evaluate the application as a new application or else reject it. 1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company shall deliver the missing documents within maximum 10 business days. In the event that the documentation demanded is not provided by the company following the execution of the agreement, SZUTEST may cancel the agreement. 1.1.10. The previously certified customers shall notify the changes in the legal status of company, notification address, 1.1.11. In case of conflict during the applications, the company shall be demanded to provide additional information and an application shall be filed to Turkish Ministry of Health, the Competent Authority, for resolution of the dispute. The costs arising from the application shall be paid by the company. 1.1.12. The application file for products with drug components shall be sent to Turkish Ministry of Health, the competent authority. The costs arising from the review of the competent authority shall be covered by the company. The company may not hold SZUTEST for delays arising from the review conducted by the competent authority. 1.1.13. Re-assessment applications shall be filed, agreements shall be signed and the requirements of the agreements shall be fulfilled at least 6 months earlier than the expiry date of the certificates, If the application date is less than 6 months before the expiry date SZUTEST may refuse the application after the evaluation of the application however if such application is accepted the Company shall accept the deadline limitations for the non-conformity corrections found during the re-assessment. 1.1.14. Supplementary documents to be provided during the applications and other technical documentation shall only be provided in digital form and files shall only be sent to e mail addresses using SZUTEST domain. Only controlled copies of documents shall be shared with SZUTEST.

Application Review and Agreement Process. 1.1.1. Applications for product conformity and ISO 13485 assessment concerning Medical Devices certification shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company shall fill in and sign the application forms completely. The documents required in the application form shall be delivered submitted to SZUTEST along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. 1.1.2. SZUTEST shall initiate the application assessment process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST may consult to the Competent Authority during the process of application assessment. 1.1.3. SZUTEST may contact the previous Notified Body or Certification Body certification body of the company or demand that the company to provide the reports and documents issued by that notified body or certification body for transfer applications. Based on the information received, SZUTEST may reject the company's application. In case no information can be obtained from the previous certification body, SZUTEST may either treat the application as a new one or reject it. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company shall perform the financial obligations provided in the agreement and deliver submit all the documentation documentation, including specifically the Technical File, Design dossier and quality management system documentation documentation, to SZUTEST within maximum 10 business daysdays at the latest. 1.1.7. As for transfer applications, SZUTEST may demand the company and the previous notified body to execute a transfer agreement with no financial value. 1.1.8. SZUTEST may contact the previous notified body or certification body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body or certification body, SZUTEST may evaluate the application as a new application or else reject it. 1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company shall deliver the missing documents within maximum 10 business daysdays at the latest. In the event that the documentation demanded is not provided by the company following the execution of the agreement, SZUTEST may cancel the agreement. 1.1.101.1.8. The previously certified customers shall notify the changes in the legal status of company, notification address, 1.1.11. In case of conflict during , quality management system, certified scope and in the applications, the company shall be demanded to provide additional information and an application shall be filed to Turkish Ministry of Health, the Competent Authority, for resolution of the dispute. The costs arising from the application shall be paid by the company. 1.1.12. The application file for products with drug components shall be sent to Turkish Ministry of Health, the competent authority. The costs arising from the review of the competent authority shall be covered by the companyagreement, if any, by means of the change notification form and application form with relevant annexes, if applicable. SZUTEST shall review the notifications of changes and determine the actions necessary to be taken and approve or reject the change subsequently. The company change may not hold SZUTEST for delays arising from require updating the review conducted by the competent authorityagreement and collecting additional charges. 1.1.131.1.9. Re-assessment applications shall be filed, agreements shall be signed and the requirements of the agreements shall be fulfilled Recertification requests are received at least 6 months earlier than before the expiry date expiration of the certificatescompany's certificate, an agreement is signed with the company, and the contractual obligations are fulfilled. If the recertification application date is less than 6 months before the expiry date SZUTEST may refuse the application after the evaluation of the application however if such application is accepted the Company shall accept the deadline limitations for the non-conformity corrections found during the re-assessment.is 1.1.141.1.10. Supplementary documents to be provided submitted during the applications and other technical documentation application shall only be provided in digital form form. Document submissions shall be made only in controlled copy format and files shall only be sent to e mail email addresses using with the SZUTEST domain. Only controlled copies of documents shall be shared with SZUTEST.