Resolution RDC No. 40/2015 of the Brazilian health surveillance agency (ANVISA), published in the federal gazette (DOU) on August 27, 2015, introduced important changes to the record (cadastro) of health products by eliminating the exception that previously existed to this procedure.
Resolution RDC No. 40/2015 fully repealed Normative Ruling No. 2/2011, as well as article 3 of Resolution RDC No. 185/2001.
Health products are divided into risk classes: class I products are considered low risk and class II, medium risk. Class III products are high risk and class IV products have the highest risk.
According to IN No. 2/2011, now repealed, class I and II health devices and materials had to be recorded, with a few exceptions that were subject to registration (registro). Registration is the mandatory procedure for class III and class IV products.
Some of the products that, despite being classes I and II, did not have to be recorded, and, therefore, were subject to registration, are contact lenses, surgical sutures, MRI equipment, dialyzer reprocessing equipment and others.
With the entry into force of RDC No. 40/2015, these exceptions ceased to exist, and now all class I and class II products must be recorded (cadastrados) with ANVISA. RDC No. 40/2015 also innovated by defining that products that had already been registered as class I or II are considered automatically recorded, keeping the same registration identification number, without the need for revalidation.
With regard to revalidation of these products, it was established that products subject to the record regime do not need to be revalidated. Therefore, maintenance of the record will be dependent on the compliance with the requirements of Good Manufacturing Practices and other applicable technical regulations.
It is important to keep in mind that, according to Resolution RDC No. 15/2014, products in risk classes I and II do not require Certificates of Good Manufacturing Practices (CBPFs, for its acronym in Portuguese). However, they are not exempted from complying with the mentioned requirements.
It should be stressed that, without prejudice to the classification of health products into risk classes, some products related to health are not considered health products, according to a non-exhaustive list provided by ANVISA in its website. For example, products used in the assessment, development, manufacturing or preparation of health products, such as machinery for the manufacture of pills and equipment for making prostheses are not considered health products.
Products used in laboratory support, as well as hospital infrastructure products such as medical waste sterilizers (except those for use in health procedures sites) and waste incinerators are also not classified as medical products. Resolution RDC No. 40/2015 entered into force 60 days after its publication, that is, on October 26, 2015.
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