On March 25, the National Administration of Medicines, Food and Medical Technology (ANMAT) issued Disposition No. 2198/2022 (the “Disposition”), through which it proceeded to modify the procedure for registration at the Registry of Medical Technology Producers and Products (RPPTM) of national and imported Groups A, B, C and D in vitro diagnostic medical products, as well as the procedures for modifications, transfers, revalidation and cancellation of registrations.
The Disposition sets forth that in view of the time elapsed since the issuance of ANMAT Disposition 2674/99 regulating these medical products, the technological advances and with the aim of achieving international regulatory harmonization and convergence, it is deemed necessary to modify the classification criteria of in vitro diagnostic medical products, as well as to review and update the procedural aspects in order to expedite the registration, revalidation and/or modification, transfer and cancellation of registrations of national and imported in vitro diagnostic medical products.
The Disposition defines in vitro diagnostic medical devices as any medical product that, used alone or in combination, is intended by the manufacturer to be used in in vitro analysis of samples from the human body, solely or mainly, to provide information for diagnostic, follow-up or compatibility purposes. These include reagents, calibrators, control materials, sample collectors, software, instruments or other items, used alone or in combination, which are intended by the manufacturer to be used for in vitro analysis of samples from the human body.
Annex I of the Disposition establishes the rules under which these medical devices are qualified, basically according to the intrinsic risk they represent for the health of the user, patient, operator or third parties involved, in Groups A, B, C or D.
By way of example, the following are included:
Within Class A: buffer solutions, diluents, culture media, enrichment media and auxiliaries intended for identification of microorganisms, washing solutions and histological stains, intended by the manufacturer for in vitro diagnostic procedures for a specific examination; instrument for preparation and processing of samples for in vitro diagnosis; and products for extraction of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), ancillary to in vitro diagnostic procedures.
In Class B, instruments used for the in vitro diagnosis of human samples that provide results of analytical determinations, except instruments intended for self-diagnosis.
Within Class C, those products which purpose is the determination of blood grouping, or histo-typing to ensure the immunological compatibility of blood and its components, cells, tissues or organs intended for transfusions or transplants, or cell administration.
In Class D, those products which purpose is the detection of the presence of or exposure to a transmissible agent in blood and its components, cells, tissues or organs, or in their derivatives, to assess their suitability for transfusion, transplantation or cell administration; or the detection of the presence of or exposure to a transmissible agent causing a potentially fatal disease and with a high or presumed high risk of propagation.
REGISTRATION
The Disposition establishes requirements according to the product’s class. In summary:
Requirements for Classes A and B:
Applications for registration in the Registry of Group A and B In Vitro Diagnostic Medical Devices, will be made by submitting a Conformity Declaration and the documents required in Annex II of the Disposition.
Once all the documents have been submitted, the National Institute of Medical Products (INPM) will have a term of 15 administrative working days to issue a decision.
Requirements for Classes C and D:
The applicant shall submit the documents set forth in Annex III of the Disposition.
In turn, for products classified in Class D, the applicant must submit a test protocol of at least 100 determinations; once submitted, ANMAT will have 110 administrative working days to issue a decision.
The registration is valid for 5 years, which can be renewed for the same period before the expiration date. In case of initiating the renewal process after the expiration date, the registration must be carried out as if it were a new medical product.
MODIFICATION
Regarding modifications, the Disposition establishes requirements according to each class of product.
Any modification to the registration of In Vitro Medical Products must be communicated to ANMAT. If the ANMAT detects that such modification was not communicated, it will have the power to suspend, cancel and/or prohibit the commercialization and request the withdrawal from the market, and even initiate the corresponding summary proceedings.
Regarding modifications with respect to Groups A and B: the person in charge shall comply with the delivery of the documentation set forth in Annex V of the Disposition.
Regarding modifications with respect to Groups C and D:
When the modifications are due to characteristic data of Group C and D in vitro diagnostic medical products, the following must be provided:
Technical name and/or descriptive name
New trademark or trade name
New forms of presentation
Modification of the information contained in the labels and/or instructions for use (without modifying any other characteristic data).
Change of shelf life
Processing plant for products of imported origin.
There will be an agile enrollment mechanism. Likewise, the applicant shall comply with the delivery of the Conformity Declaration present in Annex VI of the Disposition, which, once subscribed by the INPM, shall constitute the proof of registration in the RPPTM.
The changes must not modify the indications for use of the product, its basic methodology, nor its performance characteristics.
The requests for modification of registrations of medical products for in vitro diagnostics will not imply the modification of the expiration date of the registration, which has an original validity of 5 years.
TRANSFER
Annex VIII of the Disposition sets forth the required documentation to apply for a registry transfer.
CANCLLATION
The applicant shall submit the documentation indicated in Annex IX of the Disposition.
SOFTWARE AS MEDICAL DEVICES
The computer program or stand-alone software (hereinafter SaMD) is defined as any “computer product or application that is intended for one or more of the purposes indicated in the definition of medical product and that performs its functions without being part of the hardware of a medical product” and must be registered with the ANMAT.
SaMDs can run on a general purpose (non-medical purpose) computing platform, which includes hardware and software resources (operating system, process hardware, storage, data library, display devices, input devices, programming language, etc.). SaMDs do not require the hardware of a medical device to achieve their intended use.
A computer program will not be considered a SaMD if its purpose is to control the hardware of a medical product.
In turn, a SaMD can be used in combination (e.g., as a module) with other products, including other medical products. They can interact with other medical products, including their hardware and by other SaMDs, as well as by general-purpose software.
Mobile applications (Apps) that meet the definition are considered as SaMD.
For their registration, computer programs must comply with the Disposition, according to the corresponding risk class of in vitro diagnostic medical product; and for this purpose, the evaluation of the software design, risk management, verification, and validation of each stage of the life cycle defined in accordance with the regulations in force must be considered.
IMPORTED PRODUCTS
In the case of imported medical products, the applicants must file Representation and Commitment Letters.
The Representation Letter must contain the manufacturer’s or exporter’s authorization for the importer to market its in vitro diagnostic medical products in Argentina. On the other hand, the Commitment Letter is the notification of the manufacturer’s commitment to inform the importer that it markets its product in Argentina on any developments related to the product. These requirements may be in a single document, or separately, and must be legalized by an Argentine Consulate or by means of The Hague Apostille, and translated into Spanish by an official translator, duly legalized by Translators’ Association.
NATIONAL PRODUCTS
In case of nationally manufactured products, except for Group A and B, the risk management report must be submitted, which must be signed, in each of its sections, by a graduate professional in accordance with the technology of the product involved.
The application and the documents referred to in the annexes of the Disposition must be subscribed in its entirety, jointly, by the Technical Director and the legal representative of the applicant; and both the Technical Director and the legal representative will be responsible for the veracity of the documentation and information submitted.
In case of inaccuracy or falsity of the mentioned information or documents, the ANMAT may suspend, cancel, prohibit the commercialization, and request the withdrawal from the market of the products and initiate the corresponding summary proceedings.
The ANMAT may also inspect the manufacturing plant of Group A, B, C and D in vitro diagnostic medical products, national and imported, when it considers it is necessary to demonstrate the conformity of the product with the safety and efficacy requirements. It may also request the performance of tests and controls in the country and the presentation of complementary or additional documentation and tests when non-compliance is strongly suspected.
Disposition 2198/2022 will enter into force 60 working days after publication in the Official Gazette, i.e., June 29, 2022.
This report should not be considered as legal or any other type of advice by Allende & Brea.
