The US FDA has published a guidance document that will help the industry and the Health Agency (HA) staff determine when a software change to a medical device requires a manufacturer to submit and obtain the FDA clearance of a new premarket notification (510(k)).
- September 17, 2021 Medical Devices, Regulatory Affairs
- September 17, 2021 Regulatory Labeling, Regulatory Software & Services
While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging. Therefore, it is crucial to have a dedicated platform to handle the lifecycle changes of product labeling.
- September 16, 2021 Publishing & Submissions, Regulatory Software & Services
As many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant.
- September 16, 2021 Chemicals, Cosmetics Regulatory Services
Identification of the product category is perhaps the most crucial step to comply with the Regulatory requirements in the European market. The identification process can be quite challenging as many products fall under two (02) or more categories and are affected by different Regulatory frameworks. Such products are referred to as borderline products.
- September 15, 2021 Chemicals, Regulatory Affairs
The European Commission has updated the information requirements for chemicals registration under the EU REACH, intending to make the European Chemical Agency (ECHA) evaluation practices more transparent. The updates of the EU REACH annexes describe the information requirements for the companies that must be submitted during the chemical’s registration.
- September 15, 2021 Medical Devices, Regulatory Affairs
With the Brexit commencement, from Jan 1, 2021, there have been a lot of changes in the UK’s medical devices regulations, which the executive Regulatory Authority in the UK – MHRA has devised. Medical device manufacturers willing to enter the UK market especially, England, Scotland and Wales, will have to follow the applicable MHRA UK regulations.
- September 13, 2021 Pharmaceuticals, Regulatory Affairs
Health Authorities worldwide are initiating various programs to strengthen Adverse Drug Events (ADE) reporting of new prescribed medicines every day. An Adverse Drug Event (ADE) can be defined as any unfavorable and unintended sign, symptom, or disease associated with the use of a medicine. The safety and efficacy of new prescribed medicine is usually decided based on clinical trials.
- September 8, 2021 Medical Devices
Medical devices in Mexico are regulated by the Secretariat of Health (Secretaría de Salud). Article 262 of the Mexican General Health Law requires all medical devices to be registered with the Secretariat of Health before being placed in Mexico. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) oversees the registration process of healthcare products.
- September 7, 2021 Medical Devices
The application of software technologies in varied healthcare management, including diagnosis or treatment of a disease condition, is accelerating at an unprecedented rate. The global medical device Authorities are revamping their regulations and guidelines to address these booming device technologies.
- September 6, 2021 Medical Devices
Mexico is the second-largest market for medical devices in the LATAM region, next to Brazil, and is the import hub for Medical Devices in Latin America. The Medical devices marketed in Mexico are regulated by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), and the regulations are both stringent and complex.