Argentina informs about more upcoming changes in their medical device registration procedures. The appropriate amendments would be implemented in two consecutive steps: on March 6, 2020, and on March 16, 2020, respectively. In particular, the amendments are set forth by the Provision ANMAT 9688/19 which is focused on the improvement of the registration procedures of domestic and imported medical products. Mainly, the improvements are aimed at further digitalization of all procedures related to the registration of medical devices in Argentina.
ANMAT 9688/19: Key Points
The Provision ANMAT 9688/2019 has been introduced by the National Administration of Medicines, Food and Medical Technology and published for the first time in the National Bulletin on November 29, 2019.
ANMAT is a state agency responsible for procedures surrounding supervision and control in the sphere of healthcare and quality of drugs, chemical products, biomedical materials, medical devices and other products. It also maintains and performs all operations and procedures associated with initial registration, import, export and placing a medical device on the national market. ANMAT should also supervise compliance with any and all applicable standards in the sphere of safety and quality of medical products. The authority also participates in the International Medical Device Regulatory Forum (IMDRF) – a voluntary association of medical device regulating authorities collaborating to improve the regulatory framework and develop new effective approaches to the regulation of medical devices.
The scope of the new act covers the following aspects:
- Initial registration of Class I, II, III and IV medical products, both domestic and imported, in the Register of Manufacturers and Medical Technology Products,
- Modification of registration of the aforementioned products,
- Revalidation of registration,
- Transfer of registration,
- Cancellation of registration.
The scope of the regulation also covers products that are not medical devices but are intended to be used in the sphere of healthcare for purposes similar to medical products due to harmonized standards applicable to the similar products with the intended medical purpose based on the similar technologies. According to the document, all products falling within the scope of the regulation should be registered in accordance with the risk-based classification.
Medical Products Registration Requirements
The regulation provides special requirements for the registration process that depends on the class of the device, namely:
- According to the guidance, Class I medical products, which are not sterile or without measurement function, should be registered in the Registry of Manufacturers and Medical Technology Products under the notification procedure. Thus, the authority will perform the registration upon receipt of the appropriate application.
- For Class I medical devices other than specified above, as well as for Class II medical devices, the manufacturer shall submit the Declaration of Conformity accompanied by the documentation prescribed by the regulation. The National Institute of Medical Products (NIMP) would evaluate the documentation provided within 15 business days and provide the response. The Declaration of Conformity signed by the NIMP would constitute the confirmation of registration.
- For Class III and Class IV medical devices, the manufacturers would have to submit all the documents required by the authority, and the whole evaluation procedure would take up to 110 business days. It is important to mention that applications of this type should be evaluated not by the NIMP, but by the ANMAT.
The authority also reserves the right to require the applicant to provide clarifications or any information reasonably necessary to perform the assessment. In this case, the evaluation process and term calculation would be temporarily suspended. At the same time, under certain conditions, an applicant may require an extended period – for example, if it is necessary to present test results or to provide apostille foreign documents. In such situations, an applicant must submit the appropriate notice with the explanation of the reasons for the extension, while the final term of extension to be provided would be determined by the authority itself. If an applicant would fail to fulfill all the requirements within the term specified by the authority, the application would be rejected.
Registration Validity And Renewal, Modifications
The initial validity period of the registration constitutes 5 years. An applicant (registrant) also has a right to file for the renewal of the registration for the same period. For this purpose, a registrant shall file the appropriate request within 30 business days prior to the expiration of the initial term and provide the appropriate documentation. In this case, the notification procedure should be applied. The renewal of the validation should be confirmed by the renewal notice signed by the authority. If a registrant would fail to submit the notice within the terms described herein, the initial registration would expire, and it would be necessary to commence the whole registration process from the scratch.
The registrant shall duly inform the authority on any changes made to the characteristics of a medical product subject to registration. In case if the authority would identify any modification the information on which has not been duly provided, it has a right to suspend the registration, prohibit the marketing of the device and require the registrant to withdraw the device from the market. The procedures applicable to the registration of modifications and changes are also based on the classification of the devices.
- Modification to the registration of Class I medical devices should be made by providing the declaration (statement) to the authority. The appropriate statement signed by the authority would constitute sufficient confirmation.
- Modification to the registration of certain Class I medical devices (such as sterile or ones with measuring functions), as well as Class II medical devices should be performed by submitting the set of documents requested by the authority, including the Declaration of Conformity. The application would be reviewed by the NIMP, which would provide the appropriate response within 15 business days.
- Modification of the registration of Class III and Class IV medical devices should be performed using the agile process covering the following aspects:
- Technical name of the device or its descriptive name,
- Presentation form,
- Brand under which the device is marketed,
- Change of principal manufacturing facilities (for imported products),
- Change of sterilization method used,
- Amendments to the information contained in labels and/or instructions for use supplied with the device,
- Changes to the shelf life or the period of use.
All the aforementioned modifications should be also performed by submitting the declaration of conformity accompanied by the appropriate documents necessary to evaluate the changes made. The evaluation process would take up to 15 business days. It is also important to mention that changes and modifications do not impact the initial validity period of the registration.
In certain cases, the registrant can also request the transfer of the registration for domestic and imported medical devices. The whole process takes up to 50 business days.
Requests to cancel the registration would be processed by the NIMP within 10 business days, and then processed by the regulating authority within 20 business days respectively.
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