CHESTER, NY / ACCESSWIRE / April 24, 2017 / Repro Med Systems, Inc. dba RMS Medical Products (OTCQX: REPR) ("RMS" or the "Company") announced today the United States Food and Drug Administration ("FDA") renewed the Company's Certificate to Foreign Government ("CFG"). A CFG is issued for legally marketed devices in the U.S. that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act ("FFDCA"). A CFG is required by many market regulators in Asia, Europe, the Middle East and Latin America in order to legally sell medical devices in their territories. The renewal of this CFG confirms RMS devices have been cleared for sale in the U.S. and are in compliance with the requirements of the FFDCA. The CFG can be presented to regulators in foreign markets as part of the medical device registration process. Foreign governments often seek official assurance that products exported to their countries can be marketed in the U.S. and meet specific U.S. regulations, for example, current Good Manufacturing Practice ("cGMP") regulations and Quality System Regulations ("QSR").
"The FDA renewal of our CFG is confirmation of our product clearances and that RMS meets specific U.S. regulations including cGMPs and QSRs," said Eric Bauer, RMS Chief Operating Officer. "Our CFG allows RMS to continue our international expansion efforts and maintain our global leadership position. We are pleased the FDA recognizes the RMS Quality System meets U.S. regulations and that the FDA continues to support the sale of our products in the U.S., as well as other countries."
RMS Medical Products is the leading manufacturer of medical products used for home infusions and suctioning. The infusion product portfolio currently includes the FREEDOM60® and our latest FreedomEdge® Syringe Infusion Drivers, RMS Precision Flow Rate Tubing™ and RMS HIgH-Flo™ Subcutaneous Safety Needle Sets. These devices are used for infusions administered in professional healthcare settings as well as at home. The Company's RES-Q-VAC® line of medical suctioning products is used by emergency medical service providers in addition to a variety of other healthcare providers. The Company's website may be visited at www.rmsmedicalproducts.com.
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes", "belief", "expects", "intends", "anticipates", "will", or "plans" to be uncertain and forward looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's reports and registration statements filed with the Securities and Exchange Commission.
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SOURCE: RMS Medical Products