Vendor Section: This section provides essential information for medical device suppliers, including:

• Management Regulations: Covers procurement, installation, training, maintenance, and penalties.
• Document Submission Requirements: Vendors must submit complete documentation such as operation manuals and maintenance plans.
• Training: Vendors are required to conduct training for user units and submit training records.

For more information, visit the Vendor Section.

Medical Device Management Regulations

Scope

• Applicable to all medical devices and equipment procured by the hospital for medical use.

Inspection Content

• Vendors must provide complete documentation, including copies of procurement contracts, operation manuals, maintenance manuals, and warranty maintenance schedules.
• Electrical inspection is required to ensure the equipment's power requirements comply with hospital standards and appropriate power cords are provided.

Training

• Vendors must conduct training sessions for the user units and submit course schedules and records.

Maintenance Plan

• Vendors are required to perform regular maintenance and emergency repairs during the warranty period and keep detailed maintenance records.

Installation Coordination

• Prior to construction, vendors must submit construction plans and related documents for approval.

Penalties

• If vendors fail to provide the necessary documents, 3% of the equipment's total price will be withheld, and the warranty period will be extended by two years.

Relevant Regulations

• Involves multiple regulations, including the Medical Device Management Act and international medical regulations.

For more detailed information, visit the Medical Device Management Regulations.