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Definition of a Medical Device around the global market

According to the Therapeutic Goods Act 1989, a medical device is: (a) any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether … See more

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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 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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Cosmetics Registration in Mexico

WEBRequest for an Importation License – The company must. Register in the register of importers. Determine the cosmetic product’s tariff code. On the Ministry of Economy’s …

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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 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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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 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 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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Portugal Infarmed Registration Regulatory Authority OMC Medical

WEBPortugal INFARMED Registration Requirement. 145/2009 published on 17 June 2009 and transposed into Portuguese law Directive No. 2007/47/CE of European Parliament and …

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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 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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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 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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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 Trinidad

WEBProcess: Any inspector, if so authorised by the Minister, has the authority to examine any Customs entries of food, drugs, or cosmetics imported into Trinidad and Tobago, as well …

Category: Food Go Health

Cosmetics Registration in Kuwait

WEBThe product packages should carry the information in English or in Arabic, including the manufacturer’s name and the country of origin. All the above documents must be …

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Medical Device Registration in Kyrgyzstan

WEBThe registration dossier must be in English, with certain sections translated in Russian, and submitted electronically. Medical device registration in Kyrgyzstan is carried out …

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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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