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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.
Medsafe (Medicines and Medical Devices Safety Authority) is the New Zealand government agency responsible for the regulation and management of medicines, medical devices and other medical products.Medsafe is responsible for evaluating and approving the registration of medical products, monitoring the quality, safety and efficacy of medical products, and supervising the production and distribution of medical products. Medsafe is responsible for assessing and approving the registration of medical products, regulating the quality, safety and efficacy of medical products, and overseeing their manufacture and distribution, etc. Medsafe's main task is to ensure that medical products available on the New Zealand market comply with national and international standards and requirements, and safeguard the health and safety of the public. To this end, Medsafe maintains close co-operation with other international pharmaceutical regulatory bodies to promote the safety and reliability of medical products.If a medical device company has obtained CE marking from the European Union, FDA from the United States, or MDL/MDEL registration from Health Canada, it will need a local nominated sponsor (Sponsor) to list your product on MedSafe's WAND (Web Assisted Notification of Devices) database on MedSafe.It is important to note that the local Sponsor is also licensed in New Zealand and is solely responsible and liable for the registration and listing of devices in New Zealand by foreign companies; is responsible for the accuracy of the information in the WAND and is the sole point of contact for Medsafe.
The MHRA (Medical & Healthcare products Regulatory Agency) is under the jurisdiction of the Department of Health and Social Care (DHSC) in the UK.The quickest way for offshore companies to list medical devices in the UK is to convert using an existing CE MDR certificate, or to convert a certificate or part of a technical file of a medical device certification obtained in Australia, Canada, the European Union, or the United States of America, in accordance with the draft of the proposed recognition of Australian, Canadian, European Union, and U.S. medical device certifications published by the MHRA on 21 May 2024, which is expected to be implemented in 2025, and which is expected to be implemented in 2025. is expected to be implemented in 2025.It is worth noting that: a. To apply for registration in the UK, overseas enterprises will need a UK Authorised Representative (UKRP), who will carry out legal duties for the overseas enterprises in the UK. b. If the medical device registration certification of other proposed recognised countries is used for the conversion, the UK MHRA will not issue the UKCA certification mark. c. If the overseas enterprises do not use the certification of the proposed recognised countries for the conversion in the UK, they will need to approach the UK MHRA for the conversion of the certificates or part of the technical documents of those proposed recognised countries. to the UK, they will need to approach AB ‘Approved Body’, a third party independent certification body appointed by the UK MHRA, to apply for UKCA accreditation. d. Northern Ireland is not included in the UK medical device regulatory legislation. e. The UKCA accreditation mark will not be issued to companies that do not use the accreditation of other proposed countries for conversion to the UK.
醫(yī)療器械企業(yè)希望把產(chǎn)品投放到日本市場(chǎng)，必須要滿足日本的 Pharmaceutical and Medical Device Act (PMD Act)法規(guī)。日本厚生勞動(dòng)省（MHLW，全稱為“Ministry of Health, Labour and Welfare”）下屬部門：藥品和醫(yī)療器械局 (PMDA,全稱為“Pharmaceuticals and Medical Devices Agency”)是日本的監(jiān)管機(jī)構(gòu)。醫(yī) 療 器 械 必 須 要 由 其 市 場(chǎng) 合法授 權(quán) 代表 MAH （ Marketing Authorization Holder ）通過以下程序去注冊(cè)其產(chǎn)品。 Class I 器械 - 上市前提交 TodokedeI類器械上市前必須由其 MAH或 DMAH向 PMDA 提交一份上市前提交文件，這份文件不需要經(jīng)過 PMDA的審核和批準(zhǔn)。Class II 器械 - 上市前認(rèn)證 Ninsho作為特殊控制的 II 類器械上市前必須要經(jīng)過上市前認(rèn)證。認(rèn)證機(jī)構(gòu)（PCB）為 PMDA 授權(quán)可以進(jìn)行 PMDA認(rèn)證的機(jī)構(gòu)。Class II，III,IV 器械 - 上市前批準(zhǔn) Shonin除了特殊控制的 II 類器械外的其他 II 類器械和 III,IV 類器械必須要由其 MAH 或 DMAH 像PMDA提交上市前批準(zhǔn)的申請(qǐng)，并經(jīng)過 PMDA批準(zhǔn)后才能注冊(cè)他們的產(chǎn)品，并投放市場(chǎng)。值得注意的是：境外的醫(yī)療器械進(jìn)入日本注冊(cè)時(shí)只能由日本授權(quán)代表（MAH或DMAH）持證，境外的醫(yī)療器械制造商只獲得“醫(yī)療器械外國制造業(yè)者登陸證”（即體系審查合格證書）。
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 therapeuticThe 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.
