Hindustan Syringes and Niraj Industries receive prestigious MDSAP certification

The group companies of Hindustan Medical Devices – Hindustan Syringes and Medical Devices Ltd and Niraj Industries were among the first set of Indian manufacturers of disposable medical devices to be awarded the prestigious MDSAP quality assurance certificate. The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit of a medical device manufacturer’s quality management system (QMS) which satisfies the requirements of multiple regulatory jurisdictions to address patient safety concerns. Manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan, and the United States of America.

For manufacturers, MDSAP is of benefit as it reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities. The MDSAP certificate aims to promote globally a greater alignment of regulatory approaches and technical requirements which are based on international standards and best practices. Additionally, it also promotes consistency, predictability, and transparency of regulatory programs. MDSAP certificate is an addition to ICMED (Indian Certification for Medical Devices) that HMD received from QCI (Quality Council of India).