SUMEC TOUCH WORLD

What are some basic things to know about medical devices? The following will introduce them to you:

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1. How to distinguish between pharmaceuticals and medical devices containing pharmaceutical ingredients?
   (1) Products where the pharmaceutical component plays a primary role and the medical device plays an auxiliary role (e.g., syringes pre-filled with pharmaceuticals) are managed as pharmaceuticals.
   (2) Products where the medical device component plays a primary role and the pharmaceutical component plays an auxiliary role (e.g., drug-eluting stents, catheters with antibacterial coatings) are managed as medical devices.
   (3) Wound dressings containing antibacterial or anti-inflammatory drugs are managed as pharmaceuticals.
   (4) Traditional Chinese medicine external application products, as traditional Chinese medicine external application agents, are managed as pharmaceuticals.
2. From a clinical perspective, what are the categories of medical devices such as instruments and equipment?
   (1) Large-scale equipment, such as: CT, MRI, PET/CT, DSA.
   (2) Laboratory and analytical equipment, such as: biochemical analyzers, blood cell counters, binocular biological microscopes, urine analyzers, enzyme-linked immunosorbent assay (ELISA) readers, plate washers, biosafety cabinets, and clean benches.
   (3) Diagnostic equipment, such as: ultrasound diagnostic instruments, various X-ray machines, electrocardiographs.
   (4) Critical care equipment, such as: ventilators, anesthesia machines, monitors.
3. What are the categories of medical device standards?
   According to the "Administrative Measures for Medical Device Standards," the medical device standard system is divided into mandatory standards and recommended standards according to their effectiveness; and into basic standards, method standards, management standards, and product standards according to their regulated objects.
4. Do all medical devices need to undergo clinical trials before being marketed?
   Clinical trials are not required for Class I medical device product registration. Clinical trials are required for registration of Class II and Class III medical devices. However, clinical trials may be waived under the following circumstances:
   (1) The working mechanism is clear, the design is finalized, the manufacturing process is mature, and similar medical devices have been clinically used for many years without serious adverse events, and the intended use remains unchanged;
   (2) Non-clinical evaluation can prove the safety and effectiveness of the medical device;
   (3) Analysis and evaluation of data obtained from clinical trials or clinical use of similar medical devices can prove the safety and effectiveness of the medical device.

The list of medical devices exempt from clinical trials is formulated, adjusted, and published by the State Council's drug regulatory department.

5. Is a license and registration required to operate a medical device business?
   Medical device operations are classified according to their risk level. Licenses are required for operating Class III medical devices, registration is required for operating Class II medical devices, and no license or registration is required for operating Class I medical devices.
6. What conditions must be met to engage in medical device business activities?
   (1) A quality management organization or personnel appropriate to the scope and scale of business operations; quality management personnel should possess relevant professional qualifications or titles.
   (2) Business premises appropriate to the scope and scale of business operations.
   (3) Storage conditions appropriate to the scope and scale of business operations.
   (4) A quality management system appropriate to the medical devices being operated.
   (5) A quality management organization or personnel appropriate to provide professional guidance, technical training, and after-sales service for the medical devices being operated.
   Enterprises engaged in the operation of Class III medical devices should also have a computer information management system that meets the requirements of the medical device operation quality management system to ensure product traceability. Enterprises engaged in the operation of Class I and Class II medical devices are encouraged to establish computer information management systems that meet the requirements of the medical device operation quality management system.
7. What is the management system for medical device production activities?
   Medical device production is subject to classified management based on the risk level of the medical devices.

For the production of Class II and Class III medical devices, approval must be obtained from the provincial, autonomous region, or municipal drug regulatory authority where the user is located, and a medical device production license must be obtained in accordance with the law. For the production of Class I medical devices, registration for medical device production must be completed with the municipal-level drug regulatory authority where the user is located.

8. What content is prohibited in the instructions for use of medical devices?
   The instructions for use of medical devices shall not contain the following: assertions or guarantees of efficacy such as "best efficacy," "guaranteed cure," "complete cure," "radical cure," "immediate effect," or "completely no toxic side effects"; absolute language and expressions such as "highest technology," "most scientific," "most advanced," or "best"; statements of cure rate or effectiveness rate; comparisons with the efficacy and safety of products from other companies; promises such as "insured by an insurance company" or "money-back guarantee if ineffective"; endorsements or recommendations using the name or image of any unit or individual; statements that make the user feel they already have a certain disease, or that misleadingly suggest that not using the medical device will cause a certain disease or worsen their condition; and other content prohibited by laws and regulations.