New Requirements for Registration of Medical Devices
Comments to ANMAT Provision 727/2013
On February 4, 2013, the National Drugs, Food and Medical Technology Administration (ANMAT) amended through the issuance of Provision 727, the requirements for the application of medical devices and annulled Provision No. 5267 of 2006.
While the new regulation maintains many of the requirements of MERCOSUR Technical Regulation for the Registration of Medical Devices, approved by Resolution of the Common Market Group (GMC) No. 40 of 2000 (which has been incorporated by ANMAT through Provision NÂ° 2318/02 (which was amended by Provision No. 1285-2004 OT 2004) it also introduces some modifications to existing criteria and establishes new requirements that will be briefly described below.
Modifications and New Requirements of Provision 727/2013
There are two main issues among the novel aspects included in the new Regulation:
- The implementation of a flexible mechanism for Class I medical device registration that will apply through a DECLARATION OF CONFORMITY that will be considered as the certificate of product registration in Argentina.
- For the importation of medical devices that have been approved in other countries, ANMAT will take into account the legislation and regulatory standards (regulatory background) as well as the history or sales background of the product in the country in which the product has been authorized.
This is a radical change that has been introduced in this new regulation that no longer considers the list of high sanitary surveillance countries that were included in Annex III of the repealed rule that established that for medical devices approved in those countries, importers were exempt from filing the Certificate of Good Manufacturing Practices of the manufacturer.
Comments on the “Similarity or Equivalence Country Regulation” Criterion
This new criterion of similarity or equivalence of the regulation and legal requirements of the country in which the product has been authorized and is marketed, which has been introduced by ANMAT, considers the compliance in relation to quality, safety and efficacy of the approved product and will have an impact on the evaluation process; because depending on the requirements currently in force in the country where the product has been approved and marketed, the HA may require:
- the submission of additional documentation and tests , or the caring out of certain tests/ controls that have already been performed, to demonstrate the safety and efficacy of the product that will be imported to Argentina .
- the submission of the history of the medical device marketed in the authorized country and a letter issued by the manufacturer of the MD to the importer in Argentina, granting the provision of Techno-vigilance data , adverse event reports, technical claims, product recall (if it has taken place) including data on corrective actions or changes that have been implemented.
If ANMAT considers that the imported MD has been registered in a country that meets the criteria of equivalence in relation to the regulation currently in force in the country where the product has been approved and is marketed, the applicant will not have to provide additional information or documentation (eg GMP Certificate of the manufacturer or any additional information) that will have a direct impact on product approval time.
On the contrary, if ANMAT considers that the country does not meet the regulation equivalence criteria of a high sanitary surveillance country, it may require a GMP Inspection of the manufacturing site. The site verification can be performed during the evaluation stage or post-marketing approval. ANMAT can also require the GMP Inspection when considering that the documentation submitted is not sufficient to demonstrate compliance of the product with GMP Manufacturing Guidelines or when there is any suspicion of non-compliance in the post-marketing stage.
Other items included in the Provision
Provision 727/2013, has also included specific rules covering the following issues:
- Medical Devices that are considered or contain software: will require software validation.
- Variations and Revalidation of Medical Device registration: it sets the obligation to submit to the HA either the notification or a registry modification procedure depending on the type of variation or change made to the MD. It also establishes the requirement of the revalidation of product registration that has to be submitted within 90 days before the expiration of five years allowed for the registration.
- Instructions for Use (IFUs): the provision outlines the content of the Instructions of Use of the MD that will be submitted to the health authority and clarifies that it is necessary for the applicant to set up the IFUs according to the information required in Annex III.B. of Mercosur Technical Regulation.
- Medical Device Sales Conditions: it defines the four sales conditions that the HA assigns to MDs: a) prescription only use , b) for exclusive sale to professionals and health institutions, c) for exclusive sale to clinical laboratories and d) OTC medical devices
- Cards for Implantable MDs: it refers the data that must be included within the cards of implantable medical devices
- Human body samples container: the primary container for the preservation of human body samples that will be used to perform in vitro diagnostic examinations will be considered in vitro diagnostic devices and will require the registration by the HA
- Lab materials and elements / equipments: will not be considered medical devices unless the manufacturer has considered a use as a medical device. If so, the product has to be registered by the HA
- Medical devices family / kits and systems: in addition to the definition of medical device family, the provision includes the definition of kits and medical device systems that can also be registered through the new regulation.
- Reference to tecnovigilance: it establishes the obligation of the foreign manufacturer of the Medical Device to notify any recall and/or any corrective or preventive action that has been taken for the medical device that is currently marketed.
Current Regulation in force for Medical Devices in Argentina
As mentioned, the new provision introduces some partial changes in the registration requirements for Argentina. The rules and matters included in current regulation are listed below:
MERCOSUR Technical Regulation for Medical Devices – CMG Resolution N° 40/00.
ANMAT Provision N° 2318/02 (modified through Provision 1284/04)
REGULATED ISSUES (IN FORCE)
- Scope and Definitions (Part 1)
- Classification (Part 2)
- Registration Procedures (Part 3)
- Conformity of Information (Part 4)
- Classification Rules (Annex II)
- Official Form for Manufacturer or Importer (Annex III.A) (New Version)
- Labeling Information/Labels and Instructions for Use of Medical Devices (Annex III.B)
- Information required as part of the Technical Report (Annex III.C)
- MERCOSUR Technical Regulation for the Registration of Manufacturers and /or Importers of Medical Devices -CMG RES Nº 21/88
Provision ANMAT Nº 2319/02 (modified through Provision ANMAT N° 3433/2004)
- Site Inspection regime for GMP Verification of manufacturers of medical devices according to CMG Resolution N° 31/97 – internalized by ANMAT through Provision Nº 194/99
- Medical Device Essential Requirements for Safety and Efficacy – ANMAT Provision Nº 4306/1999