Extraordinary and Temporary Regulatory Measures
The new Resolution RDC 346/2020, issued by the ANVISA, defines applicability criteria and the procedures for extraordinary and temporary certification of Good Manufacturing Practices. The scope of the document also covers the procedures related to the initial registration of medical products used in the context of the COVID-19 outbreak, as well as the registration of changes to such products.
First of all, the new framework expands the possibility to use the approvals issued by the foreign regulating authorities. In particular, this approach would be admissible for the foreign regulating authorities that are members of the following programs:
- Pharmaceutical Inspection Cooperation Scheme,
- Medical Device Single Audit Program (MDSAP),
- Harmonization of the Good Manufacturing Practices (GMP).
The ANVISA also allows the use of the remote inspection mechanisms instead of face-to-face procedures (e.g. on-site inspections related to the certification of Good Manufacturing Practices), namely:
- Remote inspections carried out by means of videoconferencing technologies and data transmission of the purpose of the GMP verification,
- Remote inspections to be held instead of the on-site inspections of the manufacturing facilities.
The GMP certification issued under the temporary and extraordinary framework described hereabove would remain valid for two years from the date of the official announcement made in the form of publication in the Federal Official Gazette.
At the same time, the exclusions on the use of approval issued by the foreign regulating authority could not be applied for in case if the ANVISA finds the entity in question as incompliant with the requirements to be met in order to be allowed to place the device on the Brazilian medical devices market.
The scope of the new ANVISA regulation covers both medical devices and other products that could be widely used in the context of the COVID-19 outbreak (for example, certain types of respirators that are personal protective equipment and thus are actually falling outside the scope of the medical devices regulation). According to the document, the devices covered by its scope could be exempted from certain regulatory requirements – for instance, from ones related to the Brazilian Compliance Assessment System (SBAC). Additional exemptions have been also introduced regarding other low-risk medical devices facing a significant increase in demand due to the pandemic. At the same time, some flexibilities have been also implemented for even high-risk medical devices in order to expand and ensure their availability on the market during the COVID-19 outbreak. Such flexibilities include, inter alia, special notification procedures to be used instead of the general ones set forth by the current regulation.
Applicability of the New Regulatory Framework
The ANVISA regulation also provides an exhaustive list of pre-conditions necessary to be met to apply the extraordinary and temporary measures introduced therein. According to the document, the request for GMP certification should meet at least one of the following conditions:
- The medical product in question is intended for the purpose of control, diagnosis, prevention or treatment of the coronavirus disease or the respiratory illnesses associated thereto,
- The product is vitally important to maintain the patient`s life or shortages in its supply could cause additional hazards in the context of the COVID-19 outbreak.
It is important to mention that the possibility of the shortage and its potential consequences should be justified by the medical device manufacturer applying for the GMP certification. The manufacturer shall also inform about the possible scenarios related to the absence of substituting medical devices already placed on the domestic market.
The present ANVISA resolution could be renewed by the regulating authority for equal and successive periods in case if it would be reasonably necessary due to the pandemic – for example, if the on-site inspections of the foreign medical device manufacturers would be still unavailable.
It is also important to mention that medical devices covered by the scope of the present regulation should still remain compliant with the requirements set forth by the RDC 36/2015, which is the primary regulation related to medical devices. In particular, in case if the manufacturer applying for the registration is unable to provide sufficient clinical data, compliance should be properly justified by the means of other methods available. Additional justification is also needed in case if the shelf-life claimed by the manufacturer exceeds 6 months.
The new regulatory framework introduced by the ANVISA also implements a Temporary Certification concept to be used in cases when the certification could not be properly performed under the mechanisms described hereabove, providing that:
- The medical product in question is intended to be used in cases of serious health risk for the purpose of control, diagnosis, prevention or treatment in the context of the COVID-19 outbreak;
- The medical product in question is important for the patients potentially affected by the shortages in the supply of certain medical devices facing a significant increase in demand during the pandemic;
- The proper certification of Good Manufacturing Practices constitutes the only impediment to the registration and approval for the marketing of the medical device in question.
Upon the receipt of the application, the ANVISA will conduct a rigorous investigation of the current situation related to the availability of the substituting medical products and the potential impact of the shortages that could take place due to the increasing demand. The certification issued under this rule will remain valid within the whole period the appropriate ANVISA regulation remains effective. The authority also intends to adopt special mechanisms of the priority certification to be applied after the expiration of the temporary certification.
It is also important to mention that the medical device manufacturers certified under the terms of the present ANVISA regulation could be subject to inspections conducted at any time by the regulating authority. The incompliance identified in the course of such inspections could lead to the cancellation of the temporary certification. In such a case, the authority will be also entitled to impose additional restrictive measures.
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