ANVISA to allow Production Sharing of Drugs and Medical Devices
Brazilian medical device regulator ANVISA has issued a new regulation that permits some devices to be manufactured in the same area as medications provided that all Brazilian Good Manufacturing Practices (BGMP) are followed.
Previously, RDC 17/2010 article 252 prohibited the manufacture of medical devices and pharmaceutical products in the same area.
The publication of RDC 33/2015, which changes article 252 from RDC 17/2010, makes this allowance possible for some devices as well as other cosmetic, hygienic and veterinary products for manufacturers able to meet the following conditions:
- There are technical justifications that materials used for device production have compatible or higher-quality specifications than materials used to produce medications in the same facility
- Before device production begins, risk analysis is conducted to determine acceptability of the risk involved in doing so
A new ANVISA Normative Instruction, IN 02/2015 (link in Portuguese) also published lists all medical devices and other products qualifying for this new allowance; the list includes lubricants, teeth whitening products, contact lens cleaning solutions and adhesives for topical use.
Manufacturers of devices not included in IN 02/2015 may submit requests to ANVISA if they wish to produce their devices in the same facilities where medications are made. In such cases, firms should provide the regulator with dossiers containing risk analysis, data on manufacturing flow and related information.
“Many Brazilian Manufacturers that currently have different production lines to manufacture drugs and medical devices in order to comply with BGMP requirements now have the opportunity to optimize their manufacturing processes and increase their competitiveness in the Brazilian market with this update,” says Luiz Levy, Director of QA/RA at Emergo's Brasilia office. “With the evolution of technology and quality concepts, the practice of production line sharing is already a reality in many other countries, so this is exciting news for many Brazilian manufacturers.”