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Regulatory Systems


Submitted By eliemo21
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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 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.
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): 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’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.
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.
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.
Currently a medical device may be sold in Chile without governmental authorization, as there are no registration requirements.
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.
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.
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.
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.
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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