The Ministry of Healthcare of Peru has adopted a special regulation dedicated to the in vitro diagnostic (IVD) tests intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the «novel coronavirus». For this purpose, a special sanitary directive has been adopted.
The present sanitary directive on the COVID-19 IVD test is based on the following laws and regulations:
- The general law on healthcare,
- The law on pharmaceutical products, medical devices, and health products,
- Regulation on the state of emergency declared due to the further spreading of the COVID-19,
- Regulation on the temporary safety measures implemented due to the COVID-19 outbreak,
- Recommendations on the monitoring of the health of the healthcare professionals exposed to the risks associated with the COVID-19,
- Other special directives and regulations.
The present directive is intended to ensure compliance of COVID-19 IVD tests allowed for marketing and use in Peru with the applicable quality requirements. Each test should pass the appropriate registration, while each test result should be registered in the Integrated system for COVID-19 results, including the information about the place of residence of an infected person for the purpose of epidemiological supervision.
The present regulation is addressed to the institutions providing healthcare services, pharmacies, state-owned and private institutions purchasing and using COVID-19 IVD tests.
Special Requirements for Entities
According to the directive, state-owned, private, or joint entities are allowed to purchase COVID-19 IVD tests in pharmacies or directly from the manufacturer for internal use (to monitor the health conditions of their employees). At the same time, the medical devices purchased for such purpose should not be sold or otherwise provided to any third party.
Any entity performing express-testing regarding COVID-19 should be July registered in the appropriate state register, providing that the registration scope covers such permissions as “Clinical laboratory procedures,” “Express clinical laboratory investigations on biological samples” or other. The activity of such an entity would be subject to state supervision on the regional level.
COVID-19 Test: Rules and Restrictions
The directive also describes special requirements applicable in vitro diagnostic devices (tests) intended to detect COVID-19. According to the document, in order to be eligible for marketing and use in Peru, COVID-19 tests should meet the appropriate technical requirements, including the sensitivity and specificity parameters. The device should be accompanied by the instructions for use, and containers for immediate delivery should be properly marked. The directive also states that the valid ISO 13485 certificate should be provided upon request.
According to the regulation, the pharmacy shall inform the regulating authorities about the COVID-19 tests imported within 2 business days from the day the tests have been imported. The notification should contain the following information:
- The total number of medical devices imported,
- Types of the tests (express-tests or molecular tests),
- Batch numbers, and the amount of the devices within each batch.
Within 2 business days from the date the tests have been distributed, the pharmacy shall provide the regulating authorities with detailed information about healthcare institutions that purchased the tests, as well as about the number of tests supplied and the appropriate batch numbers.
The information described hereabove should be provided using the special online portal. The same rules should be followed by any and all entities in the supply chain.
The directive also emphasizes that the COVID-19 tests should be stored in accordance with the storing requirements indicated in the labeling or other information and documentation supplied with the device.
As it was already mentioned before, all COVID-19 tests marketed in Peru should be included in the appropriate state register. According to the regulation, the state authorities are entitled to:
- Conduct inspections and examinations of in vitro diagnostic medical devices stored at customs, in pharmacies, owned by private companies or state institutions purchasing such tests.
- Collect the samples needed for such an investigation.
The entities operating with COVID-19 tests should obtain the appropriate certificate indicating the sensitivity and specificity. In case if the analytical certification does not include the aforementioned criteria, the declaration from the medical device manufacturer should be provided, indicating the minimally acceptable ranges for examinations on sensitivity and specificity.
The minimal number of tests should be determined by the state authorities. In particular, according to the directive, the number should be:
- For express-tests – 200 detections,
- For molecular (PCR) tests – from 96 to 100 detections depending on the applicable requirements.
As it was mentioned before, the regulating authorities are allowed to collect samples to conduct necessary examinations. As the result, the detailed investigation report will be prepared by the authority, describing the performance of COVID-19 tests subject to examination. According to the directive, such an examination should take from 3 to 5 business days.
In case if the in vitro diagnostic medical device in question does not meet applicable requirements set forth by the technical and sanitary regulations, the regulating authority is entitled to require the withdrawal of the device from the market and revoke the permission for the appropriate batch.
The pharmacy storing such devices should destroy all items within 30 calendar days following the day the official notification has been published by the regulating authority. Upon destruction, the appropriate notification should be provided to the regulating authority within 5 business days.
Additional Rules and Requirements
The directive also sets forth a special procedure related to recording and keeping the results obtained from the use of COVID-19 tests (both express-tests and molecular ones). The document also describes the obligations of all the parties involved in operations with COVID-19 tests, including the regulating authorities, state-owned, private, and joint entities. In particular, the document outlines the spheres of responsibility of local and national regulating authorities (e.g. Directorates of integrated healthcare networks, Decentralized bodies of national healthcare authority, Regional healthcare managers). According to the directive, all state-owned, private, and joint companies which are purchasing COVID-19 molecular or express-tests are responsible for fulfilling the obligations set forth therein.
Summarizing the information provided here above, the new directive issued by the Ministry of Health of Peru establishes rules and requirements regulating the operations with the COVID-19 tests of all the types. In particular, the document describes in detail the procedures to be followed when purchasing medical devices, as well as certain limitations (e.g. the prohibition of transferring in vitro diagnostic medical devices purchased by the entity for its own needs to any third party).
The document constitutes a part of the new COVID-related legal framework developed in Peru to establish a special regulatory regime for medical devices intended to be used in the context of the pandemic. Earlier this year the Minister of Healthcare of Peru has already issued a general regulation on medical devices (both imported and manufactured in the country) intended to meet the needs arising from the COVID-19 outbreak.
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