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)?。∕HLW，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(guó)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.
Under the EU CE MDR, products requiring review by a Notified Body (NB) include: Class I (Is, Ir, Im), Class II (Class IIa and Class IIb), and Class III; after the preparation of technical documents for Class I (excluding Is/Ir/Im), they should be submitted to the EU representative for filing. Under the EU CE IVDR, products requiring review by a Notified Body (NB) include: Class A (sterile), Class B, Class C, and Class D; after the preparation of technical documents for ordinary Class A, they should be submitted to the EU representative for filing.
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.
The US FDA 510(k) registration does not apply to: Class I exempted products and Class II exempted products.
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.
According to the requirements of the US FDA, all manufacturers (including OEM processors) exporting finished or semi-finished medical devices to the US market should register their enterprises in the US FDA system.
