ANMAT Medical Device Regulations and Registration In Argentina
- Artixio Consulting
- Jul 12, 2023
- 10 min read
Updated: May 8
ANMAT is the regulatory authority that regulates the medical device market in Argentina. ANMAT is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica in Spanish. In English it translates to The National Administration of Drugs, Food and Medical Devices and is a decentralised body under the Ministry of Health, Argentina.
In this article, we will discuss about the Argentina medical device Regulations for registration with Argentina ANMAT and more about Argentina medical products.
ANMAT Regulations For Medical Devices In Argentina
Some key regulations applicable for the medical device registration in Argentina are as follows:
Provision No: | Year | Provision on |
969 | 1997 | Clinical trial regulations |
11467 | 2024 | Requirements essential for the safety and performance of medical products |
9688 | 2019 | Regarding the registration, modification, renewal, transfer or registration and cancellation of registration of medical products. |
64 | 2025 | Registration of medical products |
8194 | 2023 | Requirement for good techno surveillance practices |
3266 | 2013 | Good Manufacturing Practices for medical products |
Argentina Medical Device Classification
The medical devices must be classified based on the ANMAT classification rules provided. Argentina follows the Global Harmonization Task Force (GHTF) guidelines for medical device registration in the medical devices classification system and is divided into class I, II, III, and IV depending on the associated risk. The classification system is as follows:
Class | Risk Level |
Class I | Low risk |
Class II | Low to moderate risk |
Class III | Moderate to high risk |
Class IV | High risk |
Class Risk associated Examples in Argentina
Class I – Low Individual Risk and Low Public Health Risk (e.g., Clinical Chemistry Analyzer, General Culture Media).
Class II – Moderate Individual Risk and/or Low Public Health Risk (e.g., Vitamin B12 Test, Pregnancy Self-Testing, Anti-Nuclear Antibody Test, Urine Test Strips).
Class III – High Individual Risk and/or Moderate Public Health Risk (e.g., Blood Glucose Self-Testing, HLA Typing, PSA Screening, Rubella Test).
Class IV – High Individual Risk and High Public Health Risk (e.g., HIV Blood Donor Screening, HIV Blood Diagnostic Test).
Pre-Registration Requirements by ANMAT
Prior to registration of the medical devices, to ensure the quality, safety and efficacy of the medical products, clinical trials might be required. This is according to the complexity of the medical device.
ANMAT Clinical Trials Requirements
The Provision 969/97 of the ANMAT states about the clinical trial requirements for medical products. To conduct a clinical trial, a set of documents must be submitted and within 90 business days from the date of the procedure begins, the Administrator must issue a decision. However, this period can be suspended whenever there arises any objection or until the documentation or the compliance is complete.
Clinical trials involving humans are begun only when the results of pre-clinical trials indicate that the health risks to the subjects are foreseeable and not significant. Every clinical trial must include an Ethics Committee that is independent of any trial/researcher influence. Regarding the planning of the clinical study it must have a 2 year experimental plan, stages to be completed and its evolution over time.
For clinical trials that are to be extended more than 2 years, an annual plan of the extensions must be submitted. The total duration must not be more than 5 years. The requirements for clinical trials are as follows:
Basic documents of the medical device for trial:
General information (generic name, trade name, parts comprising it, manufacturing, processing, package, storing & installation methods used, etc…)
Information on materials
Manufacturing information or entry into the country
Operating information
General documents: Some of the general documents include:
Sponsor address, telephone and fax number, postal code, mail id
List of centres at which the study will be conducted showing the address, postal code, telephone and fax number, mail id, complexity level, lit of the professionals in charge at each centre.
Informed consent form signed consent of the principal investigator as well as other researchers involved.
IEC (Independent Ethics Committee) authorization
Pre- clinical information: In vitro and In vivo tests
Clinical Study Protocol
Reports and records
Conclusion: Safety and effectiveness, risk-benefit analysis, clinical applications that are indicated and contraindicated, possible adverse events.
A detailed version is given in the ANMAT Provision 969/97.
Argentina Medical Device Registration Process
Medical products prior to its marketing, it should be registered in the Registry of Producers and Medical Technology Products (RPPTM- Registro de Productos Médicos y Tecnología Médica).
For class I medical devices which are non-sterile, do not have a measuring function, not active and devices that appear in Annex II part A of the Provision 9688/2019, the application to register into the Registry of Producers and Medical Technology Products (RPPTM) is the sworn statement. But all the required documents must be submitted which are:
Class I registration fee receipt via sworn declaration
Registration form.
Current GMP
Test declaration
Certificate of Free Sales currently valid (imported devices)
After the application is received, the National Institute for Medical Products (INPM) signed sworn statement will be considered as the proof of registration in RPPTM.
Class II medical devices and class I medical devices other than the above mentioned, it is through a Declaration of Conformity the application for registration in RPPTM is done. The necessary documents must be provided which are as follows:
National class I & II registration fee receipt
Registration form
Current GMP
Test declaration
Risk management report (class II)
The INPM signs the Declaration of Conformity which will be considered as the proof of RPPTM registration..
Finally, for Class III & IV medical devices application to register into RPPTM, the administrator must submit the following documents:
National Class III or IV registration fee receipt.
Registration form.
Current GMP.
Label (as per the Annex III.B of Provision 2318/02 TO 2004).
Instructions for use
Technical report
Original tests (as per the essential requirements for safety and effectiveness discussed in provision 4306/99 and other specific regulations.)
Risk management report
The documentation evaluation is done by the ANMAT, a decision is issued by issuing a pertinent administrative act.
If any irregularities/ inconsistency is found in the information submitted for the registration of medical devices, the applicant will be notified once. Within a period of 30 business days, the information must be corrected. The evaluation period will be paused until the corrections are completed. More time can be requested by the administrator in the case where:
i) Class III and IV application
ii) Apostille foreign tests or documentation presentation
If the corrections are not made within the time period or if the evaluation results are not satisfactory, then the procedure will be denied.
Argentine Local Authorized Representative
Manufacturers outside Argentina who wish to register their medical devices in Argentina must appoint a local authorized representative. The representative acts as a liaison between the manufacturer and the regulatory authority.
Timelines for registration process:
The complete registration and approval process typically takes about 12-15 months. The application review process along with technical documents for class I and II devices take about 15 to 30 working days while class III and IV takes about 60 to 120 days.
Upon successful completion of the evaluation, a certificate of registration is issued for the medical device registration by Argentina ANMAT valid for a period of 5 years.
The registration fee is subject to change and is generally decided by ANMAT depending on the classification and complexity of the device.
ANMAT Fee Structure For Medical Devices
The fee structure for medical devices are as follows:
Medical Devices | Approx. Fee in USD |
Class I | 155 USD |
Class II | 195 USD |
Class III | 260 USD |
Class IV | 360 USD |
Note: This is just an approximate fee structure. The regulatory fee change from time to time. Kindly refer to the ANMAT official website to know about the current applicable fee.
ANMAT Registration Renewal Of Medical Devices
For revalidation or renewal of the Argentina medical device registration, the applicant (manufacturer or importer) should submit a revalidation request before the expiration of the registration along with the following minimum information and a corresponding fee.
Identify the type of application
i) Registration
ii) Revalidation
iii) Modification
iv) Cancellation
The code for identifying the operation authorization granted to the establishment for medical product manufacture or import.
Company name and full address of the applicant
Technical name, identification code of the medical product
Brand and model of the medical product
Medical product class classified according to classification rules
Medical device manufacturer name and full address
Legal and technical representative of the establishment - Name, position, signature of the legal representative. Name, signature, title of the technical representative.
EU/US-Approved Medical Device In Argentina
The EMA/ FDA are among the regulatory authorities that have stringent requirements for approval of products for market entry. They have strict documentation, testing, safety, quality and efficacy regulations & requirements set forward. So, a device which has already gained approval from such an authority is without doubt a device that is qualified to enter into the market.
Such a device, when seeking registration from ANMAT will have its own priority. Since the ANMAT medical device classification is similar to that of the EU, the tests and documentation needed for each class of medical device will also have similarities. As the safety and quality tests are already conducted and documented, which is the primary goal of every health authority, it calls for lesser time and cost for the registration process. It can streamline as well as expedite the registration process and market entry.
ANMAT Product Importing Requirements:
Local Authorized Representative shall ensure that the importing medical device complies with customs regulations and procedures.
Filing the necessary documentation, such as a commercial invoice, packing list, and shipping documents, with the Argentine customs authorities.
Devices must be registered and approved before they are imported into Argentina
ANMAT Documents Required For Import Of Medical Devices
Class I & II
Imported Class I or II registration fee receipt.
Registration form
Current GMP
Valid Free Sales Certificate
Letter of Representation, Letter of Commitment, Marketing history - Only for Class II
Class III & IV
Imported Class III or IV registration tariff receipt
Registration form
Current GMP
Label (as per Annex III.B of Provision No. 2318/02 TO 2004)
Instructions for use.
Technical report (as per the Annex III.C of Provision No. 2318/02 TO 2004).
Valid Free Sales Certificate
Letter of representation
Letter of commitment
Marketing history
Technical Director Appointing
As per the Article 39 of the Provision 9688 of 2019, it is stated that the applications made must be jointly and digitally signed by the legal representative and the technical director of the company. So it is important to appoint a technical director for companies that manufacture and/or import medical products. The professionals that can be registered as the technical director at companies that manufacture or import medical products are as follows:
Pharmacists: For companies that manufacture, distribute and/ or import medical products for:
Single use
Implantable
Invasive
Surgically invasive
Medical products which incorporate as an integral part a substance, if used independently, would be considered a medicine.
Sterile medical products or products that need to be sterilized before use as well as non-toxic, pyrogen free & single use products.
Pharmacists, chemistry graduates, biochemists, industrial or chemical engineers, bioengineers and other related university degrees: For companies that manufacture, distribute and/or import medical products that are not mentioned above.
ANMAT Labelling Requirements For Medical Devices
The label of medical devices must include the following:
Name of the company
Address of the manufacturer and importer (registration holder) as applicable. If the country of the manufacturing unit of the product differs from that of the legal representative, the origin must be stated.
Information that is strictly necessary for the identification of the medical device by the user and the contents of the container.
The word “sterile” whenever applicable
Batch code after the word “lot” or serial numbers
Manufacture date, Expiry date or the date before which the device must be used to assure complete safety (if applicable).
If for single use, it must be indicated.
Storage, handling or preservation conditions
Special instruction for the operation of the device
Any precautions or warnings
Identification symbol of the competent health authority followed by the medical device registration number
Name of the legally authorised technical person that is responsible for the function.
Sterilization method (if applicable)
Post Marketing Surveillance For Medical Devices
The companies that hold a medical product registration must adopt a post merker monitoring system to follow up with the performance and quality of their product released into the market. It is only through actual or use of the medical device in the real world we can find a number of new adverse events.
In Argentina, there are a set of procedures which are developed to collect the adverse events and quality failure information for medical products (not anticipated at the safety and efficacy assessment period pre- authorization) thereby implementing corrective actions. This is called as technovigilance. Provision 8054/2010 was the one which stated about the Technovigilance programme but this provision was replaced with Provision 8194/2023.
Anyone who experiences an adverse event or who has reliable knowledge about adverse events of a medical product can report it to ANMAT via a notification form provided in their website.
Apart from this, each manufacturer must put in place a continuous risk management process for the entire lifecycle of the product. If the requirements are not met or once met then it has been deviated, or devices that caused serious adverse events and still haven't taken any steps towards correcting it, quality problems… calls for recall or even withdrawal of the medical device from the market.
Conclusion
Medical device registration is a complex process as it has to satisfy all the safety and efficacy requirements. Compliance with these requirements and regulations are essential for the safety of the users. For Argentina medical products registration, it is important to comprehend the ANMAT regulatory framework. This is the key to a faster registration process.
For more details on the regulatory process, get in touch with Artixio, a globally trusted consultant for regulatory assistance. Our regional experts can guide you right from development to market entry and maintenance. Connect with us through info@artixio.com
FAQ’s
Q. What if I didn't apply for a revalidation request for medical devices before the registration expiration?
A. If the revalidation request is initiated post the expiration of the validity of registration, the ANMAT will take steps to cancel the registration of that medical device. If the administrator wishes, re-registration can be obtained through the initial registration process.
Q. What modifications allow for a faster registration mechanism for ANMAT authorised class III & IV devices?
A. Faster registration applies for registration modification for ANMAT authorized class III & IV medical devices in the following data: technical and/or descriptive names, brand presentation forms, manufacturing plant (imported product), sterilization method changes, useful life, label/instruction for use information modification (given that it is without modifying any other characteristic data).
Q. Do all domestically manufactured devices in Argentina need to submit a risk management report?
A. No, not all medical devices that are manufactured in Argentina demand the submission of risk management report. Except class I (lowest risk class) devices, all other medical devices are subjected to submit the report.
Q. What is the Helena system?
A. The Helena system is an online platform which is used for the registration, revalidation, modification of class I, II, III and IV medical devices, IVD products class A and B registration and modification and authorization of low import use IVD products as per Article 6 of disposition 2675. The user guide can be found here, Helena
References:
Comments