What is the Role of Cybersecurity in Medical Devices?
The 510(k) clearance process is a Regulatory pathway used by the United Sta
In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African Common Technical Document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.
From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).
Freyr is currently working with many Global Pharmaceutical and Consumer Health Care companies in supporting them in planning and executing the CTD conversion requirement for the existing and new product registrations in South Africa enabling them to meet the MCC mandate. For some of these global companies CTD conversion is a time consuming and a huge responsibility that needs careful planning and execution given their growing product portfolio in the African market.
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.
Medicines Control Council’s (MCC) general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP).
Medicines to be used in South Africa for both public and private sectors shall be duly registered with the national regulatory authority, the Medicines Control Council’s (MCC) in accordance with the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965 and the Regulations and Guidelines published in terms thereof.
A written notification from the Minister to the effect that the medicine is considered essential to national health; an expert report (which is not more than 2 (two) years old; a package insert (where the product has been approved) and a summary basis for the registration (SBRA) should be submitted with application.
The Registrar shall notify the applicant within 30 days of the date of receipt of the application and the Council shall, within 9 months make a decision with regard to the application.
The abbreviated medicine review process is based mainly on the expert reports of the pharmaco toxicological and clinical data.
Applications for Abbreviated Medicine Review Process (AMRP) can only be accepted if the product has been approved by the said authorities within the last three years of the license in the licensing country.
In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African common technical document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format. From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).
With the need for converting old format submissions to CTD format comes the opportunity for Market Authorization Holders (MAH) to plan and be ready for electronic submissions. Freyr can compile submissions in eCTD format and print in paper format as required by the current MCC requirement. This allows the MAHs to be prepared for future eCTD requirements from MCC and enables efficient electronic submission dossier management.
Module 1 (Administrative 1.10 Foreign Regulatory Status) requirement from Medicines Control Council’s (MCC) requires the applicant to provide a list of countries in which an application for the same product is being applied for in South Africa has been submitted, dates of submission (if available). This should detail approvals (with indications). Applicants must declare whether a marketing application for the medicine has been rejected in the countries listed under 1.10.1 prior to submission of the application in South Africa. If the medicine has been rejected, repeatedly deferred or withdrawn, then the MCC must be informed and the reasons supplied.
If no application has been submitted for registration in the country of origin, include a statement to provide the reason for this decision. It should be noted that aforementioned information is required to be provided in dossier however, it does not mean that this will help to speed up the review process.
The 510(k) clearance process is a Regulatory pathway used by the United Sta
Regulatory artwork services form a critical component of the Pharmaceutical industry, ensuring that the packaging artwork of medicinal products is accurate, complete, and compliant with the Regulatory requirements.
As the world continues to move towards digitalization, electronic submissions are becoming the norm for Regulatory Bodies across countries. In Europe, the European Union (EU) has established a mandatory electronic Common Technical Document (eCTD) format for the submission of medicinal products’ Regulatory information.
In Pharmacovigilance (PV), the examination of safety signals should be a continuous process, and Manufacturing Authorization Holders (MAHs) must have a well-defined mechanism in place to record, evaluate, communicate, and act on possible PV hazards as needed.
COVID-19 caused major disruption in Pharmacovigilance (PV) efforts, particularly post-marketing surveillance. Due to the pandemic's rapidly increasing volume of data and shifting Regulatory and consumer trends, PV leaders were forced to rethink their traditional safety data management processes and PV technology to bring unprecedented levels of scalability, reliability, and agility to their workflow.
The Food Supplements industry is one of the fastest-growing industries in the world, and it has been steadily rising in the Indian market. According to a market research report, the Indian dietary supplements market was valued at approximately USD 3924.44 million in FY2020 and is predicted to grow at a Compound Annual Growth Rate (CAGR) of 16% up until FY 2027.
The electronic Common Technical Document (eCTD) is a standard format for submitting pharmaceutical Regulatory material to Regulatory Bodies. Many countries worldwide, including China, have adopted this format.
CE marking is mandatory for all devices that are to be sold in the European Union (EU) countries. Similarly, In Vitro Diagnostic (IVD) devices must also obtain a CE marking and undergo a rigorous approval process to demonstrate their safety and efficacy. They have to abide by the requirements mentioned under the EU In Vitro Diagnostic Device Regulation (IVDR) 2017/746.
With the implementation of the European Union (EU) Medical Device Regulation (MDR) 2017/745, one of the areas that caught the most attention was the new Post-Market Surveillance (PMS) system for devices. Establishing a PMS for a device has become a mandatory task for manufacturers. The objective behind this stringent requirement is to ensure device safety throughout the product’s lifecycle.
Medical devices play a vital role in improving patient health, but non-conformities in the devices can occur even with the best quality control systems in place. Non-conformities refer to instances where a product or a process fails to meet Regulatory requirements, quality standards, or the approved in-house procedures.