Since 2008, Peter’s has been deeply engaged in the commissioned production of semi-finished and finished medical devices in China and US, and is committed to the manufacture of aseptic finished medical devices such as ophthalmology, orthopedics, endoscopy, gynecology, etc., which are mostly exported to the United States and EU markets, and the product quality and service have been unanimously recognized by customers.

Peter’s actively responded to the call of the country, deeply studied the domestic medical device registrant system, actively sought domestic partners, and successfully signed a commissioned production agreement with innovative R&D enterprises, and after unremitting efforts, it took three months to successfully obtain the production license of Class II active medical devices (electric gynecological examination chairs) on March 18, 2024, this milestone progress announced that Peter’s Technology (Suzhou) Co., Ltd. officially entered the domestic therapeutic device commissioned production market. It not only demonstrates our company's profound strength and outstanding achievements in the field of medicine, but also marks that China's drug registration system is moving towards a more scientific and efficient direction.

Obtaining the MAH production license will bring broader development opportunities, and our company will continue to strengthen the training and learning of regulations and policy documents, actively respond to changes in regulations and policies, continuously improve the quality management system, and empower China's medical device industry as a more professional and compliant CDMO. At the same time, to ensure the safety and effectiveness of the product, to contribute more to the cause of public health.

In the second half of 2024, there will be 2-3 sterile medical device products entering the registration and declaration stage, Peter’s relies on ISO 13485 and ISO 9001 to establish a complete quality management system based on the professional notified body (BSI) certification, at the same time, based on the specific requirements of domestic medical device production quality management practice (GMP), from the institutions and personnel, plant and facilities, equipment and document management, procurement and production management, quality control, non-conforming product control, adverse event monitoring, Analysis and improvement and other aspects to improve the quality management process to ensure that the whole process of medical device production is effectively controlled.

Looking forward to the future, with the in-depth promotion and improvement of the MAH system, China's pharmaceutical industry will usher in a broader development prospect. Our company will take this opportunity to continuously promote its own innovation and development, and make greater contributions to the high-quality development of China's pharmaceutical industry.