Service content-Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.

On July 9, 2012, the FDA Safety and Innovation Act was signed into a legal document, requiring the FDA to establish a new UDI system. Until September 24, 2013, the FDA issued the Final Regulation, which mandatorily required devices to be identified using UDI for sale and use.

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Medical Device Quality System

2024-06-03

Since its release in 1996, the ISO 13485 Medical Device Quality Management System Standard has been widely implemented and applied worldwide.

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NMPA registration

2024-06-03

NMPA (National Medical Products Administration) refers to the National Medical Products Administration. Established on September 1, 2018, it replaced the original "State Food and Drug Administration (CFDA)". NMPA is not only responsible for medical devices, but also for pharmaceuticals, biological products, food, and cosmetics. Like the State Food and Drug Administration, the National Medical Products Administration is the only agency responsible for the approval and registration of imported medical devices.

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MDSAP certification

2024-06-03

The MDSAP certification program aims to establish a single audit process that meets and unifies the audit requirements of the aforementioned countries, making the audit more comprehensive and effective. The regulatory agencies of the five countries above recognize the audit results of MDSAP, and production enterprises can reduce the number of audits corresponding to different regulatory agencies, thereby reducing production interference caused by audits. The introduction of MDSAP certification has standardized the audit process internationally and reduced the burden on production enterprises

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FDA factory inspection

2024-06-03

The gap between the existing quality management system and regulatory requirements
The overall design of the consulting process, including on-site rectification, documentation system, and application rectification

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Domestic Medical Device Registration

2024-06-03

Domestic medical device registration applicants and filers shall establish a quality management system related to product development and production, and maintain effective operation.

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