Framework Agreement of Importing the Medical Devices英语脏话
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Importer:
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(Hereinafter jointly referred to as the “Parties”)
tpp是什么In view of the fact that the importer will purcha the products produced by the manufacturer and ll the products to EU countries, and EU countries have incread the control and supervision of medical devices,in order to clarify that the respective responsibilities of both parties need to be performed,this Agreement is made and entered into by and between the Manufacture rand the Importer, according to the terms and conditions stated below:
Definitions
Product(s): The are medical devices. They are sold exclusively by the legal manufacturer to the importer. The Products are listed in Appendix 1.
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Medical Device: means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be ud, alone or in combination, for human beings for one or more of the following specific medical purpos:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of dia,文明礼貌演讲稿
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the
human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in MDR Article 1(4) and of tho referred to in the first paragraph of this point.
Manufacturerawe: A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;
Importer: Any natural or legal person established within the Union that places a device from a third country on the Union market.
Distributor: Any natural or legal person in the supply chain, other than the manufacturer or the importer that makes a device available on the market, up until the point of putting into rvice.
Serious incident描写桂林山水的作文: Any incident that directly or indirectly resulted, may have resulted or may be likely to result in:
+ The death of a patient, ur or any other person,
+ A rious deterioration, temporary or permanent, in the state of health of a patient, ur or any other person,
barely是什么意思+ A rious threat to public health.
Non-Serious Incident: Any malfunction or alteration in the characteristics and performance of a device made available on the market, including an operating error due to ergonomic features as well as any defect in the information provided by the manufacturer and any undesirable side effects.
Regulations (non-exhaustive)
v Directive 93/42/EC modified by Directive 2007/47/EC (only for products benefiting from the Legacy device)
v EN ISO 13485
v Regulation EU 2017/745 of 5/4/2017 (effective May 2021)
1) - Purpo of the Agreement- Subject
The purpo of this Agreement is to define the regulation responsibilities of both parties during the Products import by the Importer from the Manufacturer. The Products are defined in Appendix 1.
The provisions of this Agreement shall apply to all orders for Products placed by the importer.
2) – Liability Responsibility of the Manufacturer
2.1) Compliance with national and European legal and regulatory provisions and all other provisions applicable to the Products
The manufacturer undertakes to strictly comply with all legal, regulatory, and European and possibly international obligations in force applicable to the Products, and all other applicable provisions.
2.2) The manufacturer is obliged to comply with the requirements Directive 93/42/EC modified by Directive 2007/47/EC (only for products benefiting from the Legacy device) and the European regulation 2017/745, in particular with :
