Sunway Biology Successfully Completed Single Audit Plan for Medical Devices (MDSAP) certification audit work

In 2022-the second year of the post-epidemic era, we conducted MDSAP audit certification. Through MDSAP certification, the burden of multiple regulatory audits can be reduced. Provide predictable audit plans, optimize the allocation of regulatory resources, reduce the frequency of inspection work, and improve work efficiency through result sharing, so that customers can feel the strength of our company. MDSAP certification can be replaced in five countries respectively: FDA's regular inspection (USA);(For Class III and Class IV products) ANVISA's pre-market GMP inspection and post-market routine inspection (Brazil);(For Class II, III and IV medical devices) Exemption from on-site factory audit (Japan); CMDCAS will be forcibly replaced from 2019, as the only way to enter Canada for products classified in Class II and above (Brazil); Exemption from TGA audit, Support Method and Maintain TGA Conformance Audit Certificate (Australia).

FromFrom February 2022 to June 2022, we worked together for MDSAP certification audit for four months. Under the guidance of four audit teachers from BSI certification organization, all departments of our company have successfully completed the audit work of MDSAP.

In the first phase (On February 23 and February 24), experts gave professional suggestions on the operation of our company's system from the perspective of system documents.Due to the sudden recurrence of the epidemic, the two-phase audit was divided into two parts: the first（April 25 and April 26) During the remote audit, three experts conducted the audit from the aspects of system operation, procurement, human resources, sales, quality inspection, etc. The company's leaders paid great attention to it, and all functional departments of the company actively cooperated to successfully solve the difficulties of this remote audit. In the second part (June 21, June 22) of the on-site audit work, the two experts conducted special audits from the perspectives of production management, equipment use and design and development. Leaders and colleagues at all levels of the company attach great importance to this audit, provide efficient information requirements put forward by the audit team, and give clear and detailed answers to the questions raised by the audit teachers. To complete the audit task with high quality and high efficiency.

The audit team highly recognized the operation of our system and the level of quality management, highly praised the resources provided by the leaders in the quality system work, and highly praised the staff's work attitude and enthusiasm. In the end, the audit team reached an agreement: our company-- Nanjing Sunway Biomedical Technology Co., Ltd. meets the MDSAP certification standards,successfully completedMDSAPAudit work.

Passed smoothly this time.MDSAP audit marks that our company has entered the management track of modern medical device manufacturing enterprises with standardization, informatization and internationalization. For the company to further expand production capacity, strictly standardize production, and continuously improve product quality, service quality and company management level.