The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s regulating authority in the sphere of medical device circulation, has recently issued the updated rules regarding the registration of medical devices. The most important amendments include the implementation of online submissions for all types of applications for all classes of medical devices. The amended rules have been developed considering the core principles developed by the International Medical Device Regulators Forum (IMDRF), a group of regulating authorities focused on the improvement of medical device regulations and harmonization of rules applicable in different regions and states.
The Scope of the Regulation: Devices and Procedures
The regulation recently published in the Official Bulletin covers a wide scope of issues associated with medical devices, namely:
– Registration of both imported and manufactured in Argentina medical devices of all safety classes in the Registry of Producers and Products of Medical Technology (hereinafter the RPPMT or the Registry),
– Making changes and modifications,
– Registration renewal (revalidation),
– Registration transfer,
– Cancelation of the registration.
The regulation also covers the products that are not medical devices but intended to be used for medicinal purposes in the sphere of healthcare and based on the technologies similar to those used in medical devices. The administration reserves the right to add new devices subject to the regulation under the rules published.
According to the provisions of the regulation, medical device manufacturers and importers are obliged to register with the RPPMT within 180 days of the day the regulation takes action. All registration procedures could be performed online via the special distance procedure platform, an online interface introduced by the administration to simplify the submission process. The detailed instructions and guidelines dedicated to the use of the platform would be published on the official website of the administration. The regulation provides a simplified registration procedure for Class I (low risk) non-sterile medical devices without measurement functions. Such devices are subject to notification procedure rather than the general approval process. To perform the registration of the aforementioned devices, the manufacturer shall submit the appropriate affidavit to the National Institute of Medical Product, a branch of ANMAT responsible for medical devices. The affidavit signed by the Institute should constitute proof of the registration. Class I sterile medical devices, devices with measurement functions and Class II medical devices should be registered through the submission of the Declaration of Conformity that should be also signed by the Institute. The whole process takes up to 15 business days.
The regulation provides stricter requirements for Class III and Class IV medical devices since they are associated with a higher risk to the patient’s health. To register the devices that belong to one of the aforementioned classes, the manufacturer has to submit an application accompanied by the documents required by the administration. An application review process for such cases would take up to 110 business days.
The administration also has a right to require the manufacturer to provide additional information on clarification to the information and documents already provided if deemed reasonable. The manufacturer must correct any imperfections in the documentation within 30 business days from the first business day after receiving the appropriate notification from the administration. The application review process would be suspended until the manufacturer makes the required changes.
In some particular cases, the manufacturer has a right to require an extension of the correction period. This right is available in the following cases:
– If it is related to Class III and Class IV medical devices,
– If it is necessary to provide test results,
– If it is required to provide apostille foreign documents.
If the applicant fails to perform corrections required by the administration, the application will be denied.
Registration Validity and Modification
The initial registration is valid for 5 years and then could be revalidated for the same period of time. To initiate the revalidation procedure, the interested party must submit the appropriate request 30 days prior to the date of the expiration of existing registration.
The manufacturer is also obliged to notify the administration of any changes made to the characteristics of the medical device. If the administration detects any modification other than changes announced in advance, it has the right to suspend the registration and initiate the withdrawal of the device from the market. The change notification procedure depends on the class of the particular device.
- To notify about the changes made to a Class I medical device, the manufacturer shall submit an affidavit in accordance with the same procedure as applied to the initial registration. The affidavit submitted to the Institute would constitute the proof of change registration.
- In the case of sterile/measuring Class I medical device or Class II medical device, procedures similar to initial registration should be applied. It would also take up to 15 days for the administration to review the submission and make changes to the registration.
- Modification of Class III and Class IV medical devices is based on the agile registration mechanism through the submission of the Declaration of Conformity. The scope of changes the administration should be notified about includes any changes to the name, presentation, brand, processing plan (for imported products), sterilization methods utilized, information in labeling or instructions supplied with the device, or its lifetime duration. It is also important to notice that for certain Class III and Class IV medical devices an enhanced procedure should be applied. In such a case, the change notification review period would be extended to 75 days (comparing to the basic period of 15 days provided for general cases). Changes made to the device do not impact the initial validity period.
Transfer, Cancellation and Other Aspects
According to the regulation, the interested party has a right to initiate a registration transfer procedure that could take up to 50 business days. The interested party (importer or manufacturer) has a right to submit a cancelation request to cancel the registration of the device. In such a case, the Institute has to review the case and provide an appropriate report within 10 business days from the initial request submission. Then the administration shall cancel the registration within 20 business days from the date the report has been issued. Each medical device should be assigned with a unique identification code indicated in the document issued as the result of the registration.
The regulation also provides requirements for information to be supplied with the device. The manufacturer shall supply with the device all the information necessary for the safe use of the device. If there is a group of related medical devices, the information supplied with each of the components should contain the description of all medical devices composing the group.
The labeling of the medical device should include, among others, the following information:
– The intrinsic risk of medical device,
– The requirement to be used only by healthcare professionals,
– Free sale notice, indicating that the device could be sold directly to customers.
Other additional requirements set forth in the regulation cover certain aspects related to implantable devices, software either integrated into a medicinal product or supplied separately as an accessory, and custom-made medicinal products.
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