Last 27 August was held in Buenos Aires, the first event information relating to Traceability System Medical Products launched by the Ministry of Health of the Nation, administered by ANMAT.
Traceability affects all companies that manufacture, import and distribute medical products.
The event was aimed at Logistics managers and quality, Technical directors, Responsible for Systems and Regulatory Affairs, nacioanles and manufacturers of medical products to acquire technical knowledge about the new traceability system for medical products administered by ANMAT.
- What technologies exist serialization?
- What are the strengths and weaknesses of each technology?
- What are the challenges faced by the pharmaceutical industry in implentación system?
- How hits traceability in the supply chain?
- Regulatory Framework: Provision Anmat 2303/2014
- GS1 Standards
- Carriers and Identification Technologies
- Roles involved in the distribution chain
- What and how to identify?
- Impact of traceability in logistic processes
- Statements to the National Traceability System ANMAT
- Solution Software Traceability
- Hardware Solution Automatic identification and data capture
- Inputs Identification Solution
- Experiences with Drug Traceability
- Success stories
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Traceability of Medical Products
To ensure control of medical products and prevent the movement of those who are not legitimate, the Ministry of Health has established, a Traceability System of medical products, which must be implemented by all persons and companies involved in the distribution chain and implementation of medical products made.
This system consists of the unique and individual identification of each unit of medical product released to market, that allows to track through the steps to determine the distribution ANMAT.
The Resolution No. 2175/2013, prescribes that this Administration National, is the authority responsible for administering the system and to promulgate rules necessary for implementation. Thus, the ANMAT issued the No provision 2303/2014, which establishes the requirements for natural or legal persons involved in the distribution chain and implementation of these produce. Information medical products will join the one database managed by ANMAT.
The rule provides that the Traceability System of medical products (SNT-PM) will be implemented gradually, depending on the degree of criticality of the different categories of pmedical roducts. In the first instance, will be applied on the following implantable medical devices:
Cardiodesfibriladores / cardioversores
Electrical stimulator for hearing in the cochlea
Intraocular lenses
Cardiac pacemakers
Prosthesis internal breast
Endoprotesis (stent) coronary vascular
Column prosthesis
Hip
The National Traceability System Medical Products (SNT-PM) is a tool to validate the distribution chain and implementation of these produce, detect any abnormalities that may interfere with their quality. The purpose is to create certainty for patients. We trust that optimize distribution processes of these products, preventing the unlawful entry of products to market, as well as ensure their safe implementation.
Who should put the supports traceability products included in the Provision No. 2303/2014 are registrants (processors / importers). Distributors and public and private health care facilities that have products made by the regulations at the time of enactment the same, may continue the distribution and implementation of these to both receive from their suppliers, with corresponding identification media. Once the regulations coming into force, should inform those medical products support they receive in traceability.
