The DEADLINE for implementing UDI for CLASS I devices before FDA is CLOSE! Under FDA, compliance with the UDI rule for class I devices becomes mandatory as of September 24, 2020. That date that was initially, September 24, 2018, has already been postponed by 2 years. So be careful, there [...]
Medical devices submissions pass to electronic format with FDA In an effort to improve the effectiveness of the medical device-related pre-market submission program, the FDA today issued the Final Rule, which amends existing pre-market regulations and now requires that submissions only occur in electronic format, eliminating the need for multiple [...]
Resolution RDC n. 13, of January 27th, 2004 - Goods intended for exposure, demonstration or distribution at fairs or events At the last Hospitalar fair that occurred in May 2019 in São Paulo/SP, Anvisa seized several irregular products and closed some stands. One of the reasons was the lack of [...]
The FDA and its peculiarities in the cleaning and steam sterilization processes recommended in the IFU Medical products that must be cleaned and steam sterilized (autoclave) prior to use or in the case of thermolabile products, cleaned and disinfected prior use, are those marketed as non-sterile or those products marketed as [...]
September 30 of each year ends FDA Fiscal Year or FY. As a result of this change, there is an adjustment in the FDA fee rates. For the FY 2020, the standard and small business values increased by 6% when compared to the fee rates for the FY 2019: Check [...]
ISO 13485: 2016 and its relationship with Computer Systems Validation The newest edition of ISO 13485 was a new approach on the validation of productive processes using computer systems. They are covered by this new approach from high level language software like as ERPs, production control systems (MES) to more [...]
Consulting in Clinical Research In order to offer a complete solution to our customers, Passarni Regulatory Affairs has established a partnership in the clinical research market with GRINN. GRINN is a contract research organization (CRO) specialized in innovative study designs for Clinical Trials, Literature Reviews and Real World Evidence. They offer both [...]
What is GMP? GMP refers to the Good Manufacturing Practices Regulations defined by the Health Regulation and Health Surveillance Agencies of several countries. These regulations, which have the force of law, require manufacturers, processors and distributors of medicines, cosmetics, medical devices and food products to take proactive measures to ensure [...]
Systems Validation With the great supply of management software available along with the relatively low cost of deployment, many medical companies started to control everything via system, eliminating much of the printed documentation, bringing great benefits in the management of the company. The counterpoint to such an approach is that, [...]
Hospitalar Fairs 2019 CONFIRMED PRESENCE! Passarini Regulatory Affairs confirms its presence as an exhibitor at the 26th edition of the Hospitalar fair, which will take place from May 21 to 24, at Expo Center Norte in São Paulo / SP. During the event you can schedule a meeting with our [...]
