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Medical Device Registration in Israel OMC Medical Limited

WEBMedical Device Registration in Israel. Prepare the application dossier. This includes FDA 510 (k), CE Marking Certificate, or regulatory approval from Australia, Canada, or Japan; …

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URL: https://omcmedical.com/medical-device-registration-in-israel/

Canada Medical Device Registration OMC Medical

WEBClass III and IV: approximately 4-8 months. Registration fees: MDEL: $4,581. MDL: Depends on the class. Annual fees : $381. Classification: Class I, II, III, IV. Regulation …

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Medical Device Registration in Cambodia OMC Medical Limited

WEBDetermine the classification of the device. Appoint a local representative. Prepare application and Technical File. Make the fee payment. Once approved, the manufacturer …

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Medical Device Registration in Ecuador OMC Medical Limited

WEBMedical Device Regulation. Resolution ARCSA-DE-021-2020-MAFG – Issuance of the operating permit to establishments that manufacture, import, store, distribute, market …

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Medical Device Registration in Algeria OMC Medical Limited

WEBDocuments can be either in French or Arabic. Labels & IFUs should be in French and Arabic. Streamline your entry into Algeria's healthcare sector. OMC Medical Limited …

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Medical Device Registration in Albania OMC Medical Limited

WEBMedical Device Registration in Albania. – Devices must be registered in the National Register of Medical Devices maintained by the Control Agency of Drugs & Medical …

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Italy – Medical Device Registration (NSIS) OMC Medical

WEBIn Italy, the Manufacturer must register the medical devices in a dedicated database of the Ministry of Health before they are put into the market. The obligation to register with the …

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Medical Device Registration in Indonesia

WEBThe marketing authorization can be carried out in the following ways: Part 1: Premarket Control. Manufacturer License (ISO 13485 for QMS) Distribution License (Good …

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Medical Device Registration in Japan OMC Medical Limited

WEBMAH files the application with the Registered Certification Body (RCB) Class III and Class IV – Premarket Approval (Shonin). Devices which are not associated to any certification …

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Medical Device Registration in Iraq OMC Medical Limited

WEBMedical Device Registration in Iraq: Determine device classification. Appoint Authorized Representative. Prepare the application form and required documents. Submit it to …

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Medical Device Registration in India OMC Medical Limited

WEBAll applications are filed online via the SUGAM portal. Determine the device classification. Appoint Indian Authorized Agent. Prepare all company documents and Registration …

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Medical Device Registration in Ukraine OMC Medical Limited

WEBMedical Device Registration in Ukraine. Determine the device classification. Appoint an Authorized Representative and Notarized Body. Implement the Quality Management …

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Medical Device Registration in Libya OMC Medical Limited

WEBThe registration procedure is conducted as part of an annual purchasing program for imported medical Devices. The registration process must be carried out by a local …

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Medical Device Registration in Oman OMC Medical Limited

WEBMedical Device Registration in Oman: Appoint an Authorized Representative. Complete the application form and submit all the required documents. Once approved, the applicant …

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Cosmetics Registration in South Africa

WEBThere is an in-market control system rather than a pre-market control system. However, all formulas containing ethyl alcohol and manufactured in South Africa must be registered …

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Cosmetics Registration in Qatar

WEBA foreign company can register and sell its cosmetic products in Qatar either by importing them through a local agent who is registered and authorised to do so under Qatari …

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Cosmetics Registration in Ukraine

WEBThe Cosmetics registration procedure in Ukraine consists of two (2) main stages: Examination of the dossier for a cosmetic product. Laboratory analysis of finished …

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Medical Device Registration in Syria OMC Medical Limited

WEBMedical Device Registration in Syria. For registration, the following documents should be legalized by the Chamber of Commerce and the Syrian embassy in the country of origin. …

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