In urgent cases, please submit your question through the contact form. This information should be forwarded to the seoc using the form shown in appendix 8 to this annex. A medical device is defined in directive 9342eec as. Name and address of the manufacturers european responsible person. In general, the documentation has to be in such detail that the design, manufacture and the designed performances of the product can be evaluated, in order to prove compliance to the provisions of the aimdd 90385eec and the mdd 9342eec, respectively. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. Exporters, importers and consignees must keep copies of the forms for 3 years competent authorities can ask to see them. Request for quotation questionnaire en iso 485, aimdd, mdd.
Philhealth shall revoke the software certification if the hci failed to complete the remedial actions. Fill out, securely sign, print or email your annex vii waste form instantly with signnow. Annex i of machinery directive 200642 ecessential health and safety requirements applicable for design and manufacturing of machines general principlessummary of annex igeneral principles1. An assessment of the applicant agency, to be gleaned from the agency profile and capacity assessment form submitted with the proposal.
Annex iii regulations for the prevention of pollution by harmful substances carried by sea in packaged form. Completed tenderers identification form annex v completed legal entity form annex vii completed financial identification form annex viii if applicable, information and documentation on members of consortia and subcontractors as specified in. Select conformity assessment procedure article 42 4. The purpose of this document is to facilitate the preparation of the tender by providing an overview of the information and documents requested. Financial identification form using the standard template in. This information should be forwarded to the seoc using the form shown in. Part i is the written narrative that must be thorough and include specific details of the program services, manner and method of delivery including program services, client eligibility, subcontractor andor vendors that will provide services. Annex vii forms via theannex vii forms via the national packagingnational packaging waste database npwd katie olley. This software would be designed to meet both article 26 and reduce the. The dates were established so as to take account of the provisions of article 41 of the convention. Apply conformity assessment procedure annexes viii, ix, x, xi 7. Such offending shows a failure of duty of care and creates an uneven playing field for those who make the effort to comply with. Mds 7010 medical devices incorporating software utilizing softwarecontrolled by software.
Annex vii submission guide 1 created 24092012 annex vii submission guide for exporters this guide provides stepbystep instructions on how to submit an annex vii form prior to shipping green list waste. Annex vii fill out and sign printable pdf template signnow. Progress report for activities of the previous period. It does not tend to form a layer on the ground, unless the ground has a temperature that is below freezing, when it can form a dangerous layer of invisible ice on surfaces known as.
For completing this document, see also the corresponding specific instructions as contained in annex ic of. For completing this document, see also the corresponding specific instructions as contained in annex ic of regulation ec no 102006. Forms, permits and environmental impact assessment permits, notifications and registration transfrontier shipments of waste forms and document templates forms and document templates for waste shipments notification and movement documents. Find the most uptodate version of icao annex 8 at engineering360. Cpanel accounts include autossl, app catalog and autoinstall, and more. Form request for quotation questionnaire en iso 485, aimdd, mdd, ivdd, aotse. A g id t s b ittia guide to submitting annex vii forms via. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. Performancebased communication and surveillance pbcs. Prac cal implica ons for manufacturers peter rose, jens weirsoe, and mike wolf june 2017 175 pages effective may 25, 2017 for more information, please contact. The most secure digital platform to get legally binding, electronically signed documents in just a few seconds. Application form application for engagement of the services of banks medical consultant bmc on contract basis with fixed hourly remuneration at reserve bank of india, dehradun. The ec declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by section 1 of the directive ensures and declares that the products concerned meet the provisions of the directive which apply to them.
Annex b budget form with all required forms, s chedules, and signatures and required budget narrative. Operational templates and guidance for ems mass incident. Environment forms and document templates for waste shipments. Regulation 4 documentation 1 in all documents relating to the carriage of harmful substances by sea where such substances are named, the correct technical name of each such substance shall be used trade names alone shall not be used and the substance further identified by the. The person responsible for arranging the shipment must complete the form for each shipment before moving the waste. Forms should be kept for a period of three years from the date when the shipment starts, by the person who arranges for the shipment, the consignee and the facility which receives the waste. The form must be accompanied with a copy of the vat registration document and a copy of an official document showing name. Persistent offenders, or those engaging in fraud or misdescription, will be subject to more serious enforcement action, including prosecution.
The importer or consignee and if different the recovery facility must sign and complete the annex vii form at blocks and 14. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of. The form must be accompanied with a copy of the vat registration document and a copy of an official document showing name, address and registration number. Immediate assessment should be conducted to ascertain available resources that could be deployed to affected regions. Fp7 marie curie grant agreement annex vii, form e rea version of 14. Printing software subcontracting use of infra structure tel.
Steps for class iia medical devices compliance ce marking. Part iii of the annex was limited to broad standards stating the objectives rather than the methods of realizing those objectives. Annex vii forms must be kept by the person arranging the shipment, and not sent to us. Ec declaration of conformity and classification according to annex ix of the mdd. Annex vii list of documents plenary iccasp21 provisional agenda iccasp21add.
Jul 17, 2014 a letter was sent by the agency to exporters, producers, collectors and importers of waste yesterday july 16 to remind them of the requirement to fill out all sections of the annex vii form. A revised text for annex 8 consistent with the above principles was prepared on the basis of the recommendations made by the third air navigation conference montreal, septemberoctober 1956. Icao annex 8 airworthiness of aircraft engineering360. Annex iivii to manual on methods and criteria for harmonized sampling, assessment, monitoring and analysis of the effects of air pollution on forests part x. Annex a environmental screening form is an integral part of the environmental management framework, please read this document for guidelines. You cannot use this system for recording annex vii forms. Request for quotation questionnaire en iso 485, aimdd. By signing the form, the person arranging the export certifies the information provided is correct and that the necessary contract has been entered into with the. Identified critical humanitarian needs and gaps can be adequately addressed through the proposal. Identify applicable essential requirements article 4, annex i 5.
Assessment and guidance for the implementation of eu waste. Annex vii list of documents united nations office of. See appendix 7 to this annex for a sample communications plan form. Page 2 of 4 of annex c software certification agreement as of july 2017. Fp7 grant agreement annex vii form d version 5, 14. Application filled by applicants subbeneficiary project title scope of project and activity project description institution supportingsupervising the project.
It is a criminal offence to export green list waste other than in accordance with a fully completed annex vii form or without a valid contract in place. Development of academic reference standards page 2 of 8 project code. Send a copy of the completed annex vii form to sepa in advance of the shipment. Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails.
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