Classification of medical devices is the basis for all regulatory processes in any country. In other words, to receive the regulatory approval of your product you should start with classification. The class of your product determines how long and complicated the approval process will be. The difference between classes may be very significant. In some cases this difference amounts to many months and tens of thousands of dollars.
In many countries for low-risk products the approval processes are omitted or abbreviated. For instance, manufacturers of class I medical devices (class A for in vitro diagnostic devices) in the EU can affix the CE marking of conformity and place their devices on the European market without approval by a Notified Body. In the USA most (not all though) class I medical devices are 510(k) exempts and do not require FDA clearance to be placed on the American market. The same regulatory approaches are used in Latin American countries.
High risk medical devices incur more stringent, complicated and lengthy regulatory approval procedures. However, in some cases abbreviated and facilitated procedures are possible that significantly reduce registration time and expenses.
Classification is a complicated process that requires deep understanding of local regulatory framework. Different countries use different approaches to medical device classification. Wrong classification may be a reason for product rejection.
Classification of medical devices is the basis for all regulatory processes in any country. In other words, to receive the regulatory approval of your product you should start with classification. The class of your product determines how long and complicated the approval process will be. The difference between classes may be very significant. In some cases this difference amounts to many months and tens of thousands of dollars.
In many countries for low-risk products the approval processes are omitted or abbreviated. For instance, manufacturers of class I medical devices (class A for in vitro diagnostic devices) in the EU can affix the CE marking of conformity and place their devices on the European market without approval by a Notified Body. In the USA most (not all though) class I medical devices are 510(k) exempts and do not require FDA clearance to be placed on the American market. The same regulatory approaches are used in Latin American countries.
High risk medical devices incur more stringent, complicated and lengthy regulatory approval procedures. However, in some cases abbreviated and facilitated procedures are possible that significantly reduce registration time and expenses.
Classification is a complicated process that requires deep understanding of local regulatory framework. Different countries use different approaches to medical device classification. Wrong classification may be a reason for product rejection.
Classification of medical devices in the European Union is based on the classification rules given in Annex VIII of Regulation EC 2017/745. There are four classes of medical devices in the EU: class I (non-sterile, non-measuring), class I (sterile or measuring), class IIa, class IIb, class III. In the same way, in vitro diagnostic device classification is rule-based (Annex VIII of Regulation EC 2017/746). In vitro devices are divided into classes A, B, C and D.
The classification of medical devices in the USA is based on determining substantial equivalence of your product and a predicate device (medical device previously cleared by FDA). This is done by searching for predicate devices in the FDA database. If predicate device does not exist you will need to go through "De Novo" procedure. Medical devices are classified as classes I, II and III in the USA.
Medical device classification in Brazil is rule-based. The classification rules are listed in Annex II of Brazilian Resolution RDC 185/01, published by the Brazilian agency responsible for medical devices (ANVISA). There are following classes of medical devices in Brazil: class I, class II, class III and class IV.
To determine classification of medical devices in Argentina one uses the rules listed in Disposition 2318-2002 of Argentina's national agency ANMAT. There are four classes of medical devices in Argentina: class I, class II, class III, class IV.
First step to determine medical device classification in Mexico is using the rules set by COFEPRIS in the regulation "Criteria for medical device classification". After that you need to confirm the classification by referencing the COFEPRIS database. In Mexico medical devices are divided into classes: Low-risk, class I, class II, class III.
Classification of medical devices in the European Union is based on the classification rules given in Annex VIII of Regulation EC 2017/745. There are four classes of medical devices in the EU: class I (non-sterile, non-measuring), class I (sterile or measuring), class IIa, class IIb, class III. In the same way, in vitro diagnostic device classification is rule-based (Annex VIII of Regulation EC 2017/746). In vitro devices are divided into classes A, B, C and D.
The classification of medical devices in the USA is based on determining substantial equivalence of your product and a predicate device (medical device previously cleared by FDA). This is done by searching for predicate devices in the FDA database. If predicate device does not exist you will need to go through "De Novo" procedure. Medical devices are classified as classes I, II and III in the USA.
Medical device classification in Brazil is rule-based. The classification rules are listed in Annex II of Brazilian Resolution RDC 185/01, published by the Brazilian agency responsible for medical devices (ANVISA). There are following classes of medical devices in Brazil: class I, class II, class III and class IV.
To determine classification of medical devices in Argentina one uses the rules listed in Disposition 2318-2002 of Argentina's national agency ANMAT. There are four classes of medical devices in Argentina: class I, class II, class III, class IV.
First step to determine medical device classification in Mexico is using the rules set by COFEPRIS in the regulation "Criteria for medical device classification". After that you need to confirm the classification by referencing the COFEPRIS database. In Mexico medical devices are divided into classes: Low-risk, class I, class II, class III.
MDRC has a lot of experience in medical device classification for European, American, Brazilian, Argentinian, Mexican and Mercosur markets.
MDRC has a lot of experience in medical device classification for European, American, Brazilian, Argentinian, Mexican and Mercosur markets.
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