The group companies of Hindustan Medical Devices- Hindustan Syringes & Medical Devices Ltd, one of the largest manufacturers of Disposable Syringes in the World and the largest for Auto Disable syringes and a strong advocate for Make in India for Medical Devices and Niraj Industrieswere among the first set of Indian Manufacturers of Disposable Medical Devices to be awarded the prestigious MDSAPqualityassurance 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.
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.
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.
“We are delighted to have received this Regulatory Quality AssuranceCertificate. It aligns well with our …