This “Lessons Learned from Combination Products” poster was presented at the Parenteral Drug Association’s (PDA) Annual Meeting. Learn about the what, when, and how in accelerating new combination product development and regulatory pathways—in light of the recently finalized guidance: Good Manufacturing Practices for Combination Products.
This document is to provide a high-level overview of RCA’s MDR consultant solutions and the EU MDR requirements for manufacturers. Included is an outline of RCA’s EU MDR consultant Compliance and Implementation services based on these requirements. Both existing and new clients may be targeted as part of the marketing campaign for these new services. Download the full document below.
The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s MDR consultant team can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.
Our team of over 500 industry experts — including many expert MDR consultant, FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such
Whether you need support with New Product Development, Compliance Assurance, or help navigating a 483, Warning Letter, or Consent Decree, the pharmaceutical consultants at Regulatory Compliance Associates® can help. Our industry Expert pharmaceutical consultant services have a proven track record of success and can negotiate the potential minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience.
Our pharmaceutical consultant services highlighted in this handout include:
Whether you need support with Product Development, Formulation Development, Compliance Assurance, Clinical and Manufacturing Development, Guidance and Pathways for Biologic/Biosimilar Approval, FDA Briefing, or Application Submission, Regulatory Compliance Associates® can help.
We have a proven track record of success and can navigate the Biosimilar process with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. Our services highlighted in this handout include:
Regulatory Compliance Associates® Inc. can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing.
MDSAP is a standardized global auditing program which allows for a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to be conducted to satisfy the requirements of several global regulatory agencies and/or regulatory bodies.
MDSAP was conceived in 2012 (launched in 2014) by the International Medical Device Regulators Forum (IMDRF). The program officially completed the pilot phase in December of 2016 and manufacturers are now able to begin the process for certification. Currently 5 countries are participating in the program and they include: USA, Canada, Australia, Brazil and Japan. The World Health Organization (WHO) and the European Union (EU) are Official Observers. One special area of consideration is that manufacturers selling products in Canada have a deadline of January 1, 2019 to become certified in order to continue to sell their products on the Canadian Market. MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) in Canada. The two (2) year transition period in Canada started on January 1, 2017 and continues through January 1, 2019. At the end of this transition period, only MDSAP certificates will be accepted.
| Global Regulatory Authorities Designated Use of the MDSAP Audit Reports | |
| US – FDA | The FDA will accept the MDSAP Audit Report in lieu of FDA routine inspections.However, MDSAP does NOT apply for certain types of regulatory inspections including:· “for cause” inspections· “compliance follow-up” inspections; or· pre-or post-approval inspections for PMA (Premarket Authorization) |
| Canada – HC | MDSAP will replace the Canadian Medical Device Conformity Assessment System (CMDCAS) by the end of the (2) two year transition period in Canada [January 1, 2017 to January 1, 2019]. After the transition period ends in Canada, only MDSAP certificates will be accepted. |
| Australia – TGA | MDSAP Audit Reports may be used to support compliance with the medical device authorization requirements (unless the particular medical device is excluded or exempt from the requirements) |
| Brazil – ANVISA | MDSAP Audit Reports may be used to support the technical evaluation of the premarket and post-marketing requirements. |
| Japan – MHLW and PMDA | MDSAP Audit Reports may be used to support the premarket and postmarket requirements. |
MDSAP audits must be conducted by recognized Auditing Organizations (AO) authorized by the participating global regulatory agencies and/or regulatory bodies pursuant to the MDSAP requirements. These will be conducted on an annual basis based on a (3) three year certification cycle.
During your MDSAP audit, you should expect the Auditing Organization to cover all elements of ISO 13485 (Management, Device Marketing Authorization, Measurement and Analysis, Medical Device Adverse Events Reporting, Design and Development, Production and Service Controls, and Purchasing) with a heavy emphasis on:
Traditionally, manufacturers selling their products globally were faced with the challenge of being audited by multiple regulatory authorities causing disruption to manufacturers. MDSAP evolved because it was recognized that a single audit would be more efficient while ensuring the Quality Management System was thoroughly covered during an audit. It also provides consistency in the audit process and minimizes the burden on resources. All important factors when you consider efficiency goals within an organization.
*Note, EUDAMED is expected to be operational in March of 2019. Note this date is subject to change.
