Access to International Markets
Integrated approach, regulatory strategy, regulatory expertise, and market vision. Efficient and secure access to international markets.
Maytal is able to support medical device manufacturers in gaining access to the following international markets.
In all these regions, Maytal’s experts, together with their local partners, can:
• Prepare the necessary documentation for the Medical Device Dossier to be submitted to the local Competent Authority
• Manage communications with the Authority during the review process
• Provide local representation services (Local Agent), as required for foreign manufacturers in each of these markets
• Handle the maintenance of registrations, managing license renewals well in advance to ensure uninterrupted market access
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Tailor-made solutions at every stage of the journey.
Registration in Australia
To register a medical device in Australia, a Sponsor (the Local Agent in Australia) must submit an application to the Therapeutic Goods Administration (TGA) to include the device in the Australian Register of Therapeutic Goods (ARTG).
Access to the Brazilian market
The registration of medical devices in Brazil is regulated by the Agência Nacional de Vigilância Sanitária (ANVISA)and follows two main pathways: Notification for low-risk devices (Class I and II), Registration for high-risk devices (Class III and IV)
Registration in Japan
To register a medical device in Japan, manufacturers must obtain approval from the Pharmaceuticals and Medical Devices Agency (PMDA) and follow a structured process
Registration in India
Foreign manufacturers seeking to register a medical device in India must appoint a local Indian agent to handle the application with the Central Drugs Standard Control Organisation (CDSCO).
Regstration in Saudi Arabia
In Saudi Arabia, most devices require a Medical Device Marketing Authorization (MDMA) from the SFDA before market entry.
Registration in United Arab Emirates (UAE)
Manufacturers aiming to sell medical devices in the UAE are subject to device classification and, in some cases, registration.
Registration in Singapore
The main regulatory authority in Singapore is the Health Sciences Authority (HSA).
Registration in Isreael
To access the Israeli market, medical devices must be registered with the Israeli Ministry of Health (AMAR) under the Medical Devices legislation.