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Regulatory Systems

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Conformity Assessment Elements for all IVDD
The major elements of a conformity assessment system are: * A quality management system (QMS) * A postmarket surveillance system (PMS) * Summary technical documentation * A Declaration of Conformity * Registration of manufacturers and their IVD medical devices with the regulatory authority.
**Conformity: A declaration by the IVDD manufacturer that the device is safe and performs as intended.
Ref: Regulatory Affairs Professional Society; Fundamentals of International Regulatory Affairs, Second edition
Conclusion: Every country has variations in the way IVDD is being regulated. With different classifications, regulatory body etc. I would recommend you to decide on a few specific countries which would be the potential market for your device (within Latin America) and then you will be able to narrow your research on its regulatory pathway.

There are some common elements that comprise the approval process and required submission documentation for medical device approval in many Latin American countries. These include: * A Technical File or Report similar to a CE Technical File (technical description, device safety test results, biocompatibility data, labeling, etc). The required amount and type of information varies depending on the country. * A Certificate of Free Sale (CFS) issued by the public health authority in the country of origin, whichdemonstrates that the device is cleared for sale in the US, Europe, or another country which has an established trade agreement with the country where registration is desired. * Product registration in most countries is valid for 5 years * Most countries divide devices into four risk classes (I, II, III, and IV or similar), ranging from low risk to high risk. * Many countries require certain regulatory documents to be translated by a qualified individual into Spanish or Portuguese, as applicable, and notarized.
In recent years, efforts have been made to harmonize legislation in Latin American countries in a manner similar to the European Union. However, no legislative agreements have yet been definitively established, and local laws continue to vary. As a result, some countries may require minimal information for device registration, while others require substantial supplemental technical information for the same device. It is helpful to have local representatives as part of one’s regulatory team who are knowledgeable about the local cultures and laws to facilitate preparation of documents for submission, and to aid in navigating importation and distribution requirements.
Brazil
Brazil represents the largest medical device market in Latin America. Brazil is one of the most recent Latin American countries to adopt medical device regulation. Nevertheless, Brazil’s device approval process is notoriously lengthy and submission costs are the most expensive in Latin America. Brazil’s regulatory agency, ANVISA, generally employs a higher level of scrutiny during the review process compared to other Latin American countries. Device approval requires certification to Brazil’s Good Manufacturing Practices (B-GMP, similar to FDA GMP), which can take up to 2 years to obtain due to the enormous backlog in facility auditing. After device approval, follow up B-GMP inspections are conducted every 2 years. Recent regulation has established an abbreviated registration process called “Cadastro” for lower risk devices, which permits circumvention of GMP inspection.
Documents required for submission in Brazil include a Trade Permit issued by the State, samples of labels and instructions for use translated into Portuguese, and a description of all manufacturing and quality control process steps. A Technical Report is required which includes a list of safety relevant components translated into Portuguese.
Mexico
Like Brazil, Mexico’s traditional approval process for medical devices is notably long (12-18 months). In 2010 a simplified equivalency process was implemented in Mexico for devices that are cleared for sale in the U.S. or in Canada, which can shorten the review process to as few as 30 days. The fast track process requires technical documents to be translated into Spanish, and includes the following elements (among others):
U.S.fast-track required documentation (all must be translated into Spanish and notarized): * Certificate to Foreign Government (CFG), a FDA issued document for export of products that can be legally marketed in the U.S. * Establishment Inspection Report (EIR) –an FDA site audit report; * A copy of the 510(k) or PMA documentation * Canadian fast-track required documentation: * A copy of the Medical Device License (MDL) (notarized Spanish translation); * CAN/CSA ISO 13485 quality system certificate; * ISO 17021 Certificate (Proof of CMDCAS accreditation of third party quality system auditor)
Argentina
Argentina’s device registration time currently averages 4-6 months. Required documentation for registration includes, among other elements, a Certificate of Free Sale (CFS), a notarized declaration of Good Manufacturing Practices translated into Spanish by a qualified translator, and instructions for use translated into Spanish.
Venezuela
Venezuelan law specifies 20 working days for the device approval review process. Because the Venezuelan Ministry of Health is currently working with reduced hours of operation, actual turnaround time for product registration is 1 to 3 months. Registration requirements include provision of 3 letters of recommendation from physicians that have used the device in another country where the device is approved. Sterilized devices must also be tested by a local accredited institution as part of the approval process.
Peru
Device registration in Peru requires a Certificate to Foreign Government (CFG) (FDA issued document for export of products that can be legally marketed in the U.S) and a Letter of Authorization.
Chile
Currently a medical device may be sold in Chile without governmental authorization, as there are no registration requirements.
Asia
Japan
Japan is one of the largest markets in Asia for medical devices. Medical devices must be registered with Japan’s medical device regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA). Japan classifies devices into four risk categories (Classes I, II, III, and IV). In addition to implementing an ISO 13485 compliant quality system, manufacturers of high risk medical devices (Class III and IV devices and some Class II devices) mustundergo a rigorous quality system audit by the PMDA. Higher risk devices also require submission of a Summary Technical Document (STED) to demonstrate safety and performance.
Historically, the Japanese review process has tended to take anywhere fromabout 8 months to 21 months for approval, depending on whether a device is determined to be substantially equivalent, improved, or a brand new medical device per the Japanese regulation. Recently,PMDA has implemented an action program with the intention of accelerating the review process. Activities include hiring more device reviewers, allowing for more subcontracting of clinical studies, and an overall reorganization of the review department within PMDA. Review time for device approval in 2011 was reduced to between 5 and 10 months, depending on device type. China
Development and reform in China are causing medical device regulations to evolve at a rapid pace. China’s medical device regulatory authority, the State Food and Drug Administration (SFDA), classifies devices into 3 risk categories.Device approval includes submission of a dossier to the SFDA as well as type testing. For Class II and III products, SFDA does not accept Notified Body or CB Scheme product safety test results; type testing must be conducted by a SFDA recognized test laboratory on Chinese soil to the Chinese safety standard (which is similar to the IEC 60601-1 standard). There is generally a large back log for type testing. Manufacturers wishing to import medical devices must also submit a notarized quality system certificate demonstrating compliance with ISO 13485 or FDA GMPs. Class III products manufactured outside of China are subject to an onsite product audit prior to registration approval. Class III devices are also likely to require clinical studies conducted in China prior to approval, in particular for devices which contact the central nervous system. For devices which do not require clinical studies, the total product registration time can take approximately 12-18 months.All regulatory submission documents must be in both Chinese and English; translation costs can be significant.
Korea
As in Japan, Korea’s regulatory authority, the Korea Food and Drug Administration (KFDA), classifies devices into four risk categories (Classes I, II, III, and IV). For Class II, III, IV devices, registration is obtained by submitting a Technical File and conducting type testing by a third party. For some higher risk devices, the technical file may also require clinical study data as part of the submission. Companies must also obtain certification to Korean Good Manufacturing Practices (KGMP) via a third party organization which works together with KFDA to conduct a compliance evaluation.
India
In India, medical devices are classified as drugs. Only some devices are regulated; the government supplies a list of about 40 categories of products which require product registration. It is expected that more products will require registration in the future. Registering a device in India requires, among other things, an ISO 13485 certificate for the manufacturer’s quality system and an authorization letter from the Indian government. A meeting with the government for a fee prior to applying for this authorization can help pave the way for approval.
Singapore
Regulations in Singapore have recently changed to require product registration for most medical devices. Devices are classified into four risk categories (A, B, C, D). Products which have already been approved in another market such as the U.S., Canada, or Europe may follow an abbreviated registration process.
Hong Kong
Hong Kong does not currently require medical devices to be registered in order to be commercialized. While registration is voluntary, it is likely that registration will be required in the future.
Conclusion
While U.S. or European approval of a medical device can substantially ease the burden of registration and approval in other countries around the world, harmonization of medical device regulation is still far from being realized. In developing countries in particular, the regulatory approval process is evolving and dynamic. In Latin American and in Asia, language and translation efforts impart a cost and schedule impact to the registration process, and should be considered in regulatory strategy planning. In such markets, installing a local presence to work closely with regulators and to facilitate importation and distribution of product is an important asset for successful approval and commercialization of medical devices.

- In Latin America social security and public sectors represent the largest financiers of health care
- Many of these countries have compulsory packages of basic health care benefits
- Reimbursement policies seem to be largely country specific
Venezuela's Reimbursement Method
- In Venezuela you have the private sector that consists of service providers and health insurance companies. These organizations offer care from basic to specialized in exchange for direct payment.
- You also have IVSS (Venezuelan Institute of Social Security) and the Ministry of Popular Power for Health (MS) that make up the public sector. Main financial source of public spending on health care is the central government that funds the MS.

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...介紹香港現行的金融監管機制,並說明其在香港金融發展中擔當的角色. 簡報重點: 有關課題的背景 現行的運作方式怎麼樣? 現行模式著重哪方面? 現行模式對香港和中國的經濟發展起了什麼作用? 有沒有可以進一步改進的地方? • 香港金融管理局的有關背景 • 有關香港現行的金融監管機制的背景與其運作方式 • 金融監管機制在香港金融發展中擔當的角色 • 金融監管機制對香港和中國的經濟發展起了什麼作用 • 現行金融監管機制可改進的地方 一、香港金融监管现行机制有漏洞   现时,香港金融业市场采用的监管模式,是由不同监管机构管理不同职能及机构,例如保监处监督保险业、金融管理局监察金融机构(如银行及存款公司)、香港交易所监管上市公司以及证监会监管投资产品。这种模式往往衍生出灰色地带,在监管上造成不能避免的难处。   例如,雷曼迷你债券的苦主购买的产品是经由证监会批核上市,但购买的渠道却是透过银行。对于监管责任归属,金管局与证监会各有不同看法。因此,迷债苦主除了与银行交涉,还要奔波金管局与证监会之间,寻找主持公道的仲裁机构。 三、现有的监管体系   1、目标监管“双峰模式”   目前,国际上最接近“双峰模型”的金融监管是澳大利亚和荷兰。澳大利亚已成立了两个跨部门的监管机构:针对金融领域系统性风险进行审慎监管的“金融稳定委员会”和针对金融机构商业行为规范进行监管的“消费者保护委员会”。并非由于危机或者失败,而是要金融更加自由化和现代化—在提供高质量服务的同时具有高效率。澳大利亚的金融监管改革是系统的、有计划的和互动的。改革并不是由于危机或者失败,而部分是由于政策制定者希望金融更加自由化、更加现代化,从而增强其效率和国际竞争力。澳大利亚的改革以“回归根本”而闻名,主要是努力为金融法规建立清晰的概念基础。改革的结果并不是实现全方位的大监管,而是建立一个以目标为基础的体系。   第二个跨部门监管机构是澳大利亚证券投资委员会(AustralianSecurities Investment Commission,简称ASIC),它除了拥有其前身在证券监管领域的职责以外,还承担消费者保护和维持市场诚信的职责,但不承担审慎监管职责。关于所有公司和证券相关活动的商业行为、披露要求、市场行为和解决争端的职责集中于ASIC 手中,这种安排旨在优化相关监管规定,从而实现不同产品和服务之间的竞争中性、透明性和可比性。为使其监管决策不会对竞争设置不合理障碍,ASIC 必须与主管竞争的当局,澳大利亚竞争和消费者委员会密切合作。   2、英国:经典单一监管机构   英国自新千年伊始对金融监管体制实行了全面改革,建立了单一的金融监管机构。、从1997年始,英国对其金融监管体制进行了全面改革,将其银行监管的职责将转移到一个单一的监管机构,英格兰银行将负责整个金融体系的稳定。根据改革决定,10家机构进行合并,组成单一的金融监管机构。1997年10月,证券投资局更名为金融监管局(FSA),1998年起,英格兰银行的银行监管职责移交给FSA。FSA依法行使监管权力。2001年12月1日,FSA依照《2000年金融服务和市场法》(简称FSMA或《2000年金融法》)规定,正式行使其对金融业的监管权力和职责,直接负责对吸收存款业、保险业和证券投资业的监管。FSA也获得了一些其前任监管机构所没有的监管权力,例如关于消除市场扭曲或滥用、促进社会公众对金融系统的理解和减少金融犯罪等。3、非传统式分业监管   当前,美国的金融监管架构很大程度上仍然是分业的,但已...

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