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医疗器械企业希望把产品投放到日本市场，必须要满足日本的 Pharmaceutical and Medical Device Act (PMD Act)法规。日本厚生劳动省（MHLW，全称为“Ministry of Health, Labour and Welfare”）下属部门：药品和医疗器械局 (PMDA,全称为“Pharmaceuticals and Medical Devices Agency”)是日本的监管机构。医 疗 器 械 必 须 要 由 其 市 场 合法授 权 代表 MAH （ Marketing Authorization Holder ）通过以下程序去注册其产品。 Class I 器械 - 上市前提交 TodokedeI类器械上市前必须由其 MAH或 DMAH向 PMDA 提交一份上市前提交文件，这份文件不需要经过 PMDA的审核和批准。Class II 器械 - 上市前认证 Ninsho作为特殊控制的 II 类器械上市前必须要经过上市前认证。认证机构（PCB）为 PMDA 授权可以进行 PMDA认证的机构。Class II，III,IV 器械 - 上市前批准 Shonin除了特殊控制的 II 类器械外的其他 II 类器械和 III,IV 类器械必须要由其 MAH 或 DMAH 像PMDA提交上市前批准的申请，并经过 PMDA批准后才能注册他们的产品，并投放市场。值得注意的是：境外的医疗器械进入日本注册时只能由日本授权代表（MAH或DMAH）持证，境外的医疗器械制造商只获得“医疗器械外国制造业者登陆证”（即体系审查合格证书）。
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.
