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The United Arab Emirates, or UAE for short, with its capital in Abu Dhabi, is an Arab country bordering Saudi Arabia. In the UAE, medical devices and in vitro diagnostic medical devices are regulated by the Drug Control Department under the Ministry of Health and Prevention (MOHAP).
It is worth noting that foreign companies in the UAE need to find a legitimate local agent to submit medical device classifications and registrations and to communicate with MOHAP. At the same time, the local representative in the UAE also has a very important role that cannot be replaced, that is, the applicant for the import permit, only through the local representative can be carried out after the product has been certified import permit application and issuance, which means that your local representative still need to assist you to complete the subsequent import issues.

SFDA, The Saudi Food and Drug Authority. The body responsible for regulating, supervising and monitoring food, medicines and medical devices, as well as setting mandatory standards and norms, and for monitoring and/or testing activities in laboratories of the SFDA or other agencies. In addition, the SFDA is responsible for consumer certification in all matters relating to food, drugs and medical devices and all other products and supplies.
The Saudi Medical Devices Sector (MDS) plays a key role in ensuring the safety, efficacy and performance of medical devices under comprehensive legislation and regulation. The Saudi Medical Devices Regulatory Framework is aligned with international practices in terms of harmonisation and convergence, and it chairs the Global Harmonisation Working Party (GHWP) and is an active member of several technical committees of the IMDRF and ISO.
In December 2019, Saudi Arabia launched a new harmonised electronic system ‘GHAD’, which replaces the existing systems for marketing, registration and authorisation of medical devices (MDMA, MDNR and SFDA). From July 2021, local and foreign medical device manufacturers will need to register or renew their licences under the new GHAD system.
It is worth noting that a legal Authorised Representative (AR) needs to be identified locally to communicate with the SFDA for registration certification prior to SFDA registration in Saudi Arabia.

The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating medical device activities in Brazil. Before the product registration process can begin, the product first needs to be categorised and ANVISA classifies the product into four categories i.e. Class I, Class II, Class III and Class IV, with a rise in the risk category. In order to simplify the registration process for risky devices in lower risk categories, in September 2022 ANVISA simplified the registration process for Class I and Class II medical device products, with the previous registration pathway, Cadastro, being changed to Notification.There are two pathways for registration of products in Brazil, Notification and Registro. Products with a lower risk level (Class I and Class II products) are registered through the Notification route, while products with a higher risk level (Class III and Class IV products) can be registered through the Registro route.
Current Medical Device Regulation: RDC 751-2022 (effective 1 March 2023, repealing the previous regulation RDC 185/2001)
It must be stressed that: a. foreign companies outside of Brazil need to be certified to Brazil to find a legally authorised representative (BRH), and can only be held by the authorised representative; b. the product meets the medical device regulations and electrically charged products need to be done before applying for the INMETRO certification, with Bluetooth need to be done ANATEL certification; c. the product's registration application form, instructions, labels must be provided in Portuguese, and other technical documents can be Portuguese. c. The product's registration application form, instruction manual and labelling must be provided in Portuguese, while other technical documents can be in Portuguese, Spanish or English.

TGA registration in Australia, TGA is short for Therapeutic Goods Administration, the full name of the Therapeutic Goods Administration, which is the oversight body for therapeutic goods (including medicines, medical devices, genetic technologies and blood products) in Australia. the TGA carries out a range of accreditation and supervisory and regulatory work to ensure that therapeutic goods supplied in Australia meet applicable standards and to ensure that therapeutic levels of the Australian community The TGA conducts a range of review and regulatory activities to ensure that therapeutic commodities provided in Australia meet applicable standards and that the Australian community's level of therapeutic
The regulatory framework is designed to determine the management of public health and safety, while at the same time relieving businesses of any unnecessary regulatory burdens. In fact, the regulation requires that any product must be registered through the Australian Register of Therapeutic Goods (ARTG) before it can be manufactured or sold in Australia. ARTG is a computerised database of approved products that have been found to meet human safety requirements. ARTG is a computerised database of approved products that have met human safety requirements.

Unique Device Identification (UDI) for medical devices is a series of numbers, letters or characters created by globally recognised device identification and coding standards, which includes Device Identification (DI) and Production Identification (PI), used to uniquely identify a medical device, and is regarded as a unique ‘identity card’ for medical device products in the supply chain. UDI is regarded as the only ‘identity card’ for medical device products in the supply chain.

For new customers, product registration and listing services are provided at a fee; for existing customers (assisted by our 510(k) agent registration), product registration and listing services are provided free of charge.