Assembling medical equipment also requires registration of the whole machine

When the drug enforcement agency of a local drug administration conducted an inspection on a medical institution, it discovered that the “combined cervical three-in-one system for diagnosis and treatment of cervix” used in a hospital in the area consisted of three different types of medical devices. Hospitals and retailers could not provide a complete machine registration certificate. .

After investigation, the device was delivered to the hospital on October 2, 2009, and it was started after the installation and debugging were normal. "Cervical comprehensive diagnosis and treatment of three-in-one system" is mainly composed of three parts: optical electronic colposcope, high-frequency surgical treatment instrument (LEEP knife) and surgical fume smoke purifier. Among them, the optical and electronic colposcope is marked with a registration number, manufacturer, etc. The production date is September 25, 2009. The high-frequency surgical instrument is an imported instrument with a registration certificate number, manufacturer, etc. The entry inspection and quarantine date is October 17, 2009. Surgical smoke purification smokers do not have product registration information.

In order to increase the selling point to assemble medical equipment, should it be registered?

The above-mentioned "three-in-one system" is a combination of colposcopes, imported high-frequency surgical instruments, and surgical smoke-purged smokers manufactured by other manufacturers. The purpose is to increase product selling points.

Regarding whether or not the above products require registration of the whole machine, law enforcement officers have different opinions.

The first opinion is that there is no need to register the whole machine. The reason is: "The cervical three-in-one system for comprehensive diagnosis and treatment" does not belong to the category of medical equipment. It only integrates two kinds of medical instruments, colposcope and imported high-frequency surgical instrument. A surgical smoke purifying smoke device that is under the management of a medical device. There is no necessary connection between the three kinds of equipment, colposcopy, high-frequency surgical treatment instrument can be used alone, combined together mainly for the convenience of doctors, and both are legitimate products with a registration certificate, doctors use it for surgery is legal Yes, it cannot be punished as a medical device without a registration certificate.

The second opinion is that registration of the whole machine must be carried out on the grounds that the device is inseparable from the aspects of appearance, publicity and use manual and usage.

In appearance, the three components are integrated. Colposcopes and high-frequency surgical instruments are connected together through a console, and the name of the "combination of cervical and cervical integrative diagnosis and treatment system" is marked on the operating table. The configuration of the “cervical comprehensive diagnosis and treatment system” specified in the brochure clearly includes the following: electronic lens main body, lens support part, avatar workstation configuration, operating system, high frequency electric knife, and surgical smoke purifying smoker. The operating system includes LEEP video editing functions. This further proves that colposcope, high-frequency electric knife and smoke purifying device are the components of the cervical comprehensive diagnosis and treatment system.

In use, the diagnosis and treatment of gynecological cervical disease is a coherent process. Colposcopy can not only find lesions, but also can make the surgical vision more clearly, and track the recovery of postoperative wounds. Therefore, the "Chronic Comprehensive Diagnosis and Treatment Triple Play System" is a complete machine that functions by means of a combination of components.

According to Article 28(2) of the “Measures for the Registration of Medical Device Registration Regulations,” the whole machine that has already been approved for registration must be registered. Optical-electronic colposcopes and high-frequency surgical instruments are approved medical devices that have medical device registration certificates. Combining them into a "triple cervical comprehensive diagnosis and treatment system," they should perform registration procedures for complete machines. Since the operating company and the use unit cannot provide the whole machine registration certificate, it can be regarded as a medical device without a registration certificate.

Is the inspection date lagging behind the date of use? Is it legal?

The legality of high-frequency surgical instruments in this case is also one of the focuses discussed by law enforcement personnel. The entry date of the high-frequency surgical instrument is September 7, 2009, and the entry inspection and quarantine date is October 17, 2009. However, the installation and commissioning time of the product is October 2, 2009. This shows what?

One view is that although the high-frequency surgical treatment instrument has a certificate of registration, its inspection and quarantine certificate is obviously forged. According to the relevant provisions of the "Measures for the Supervision and Administration of Imported Medical Devices," the high-frequency surgical instrument is a high-risk category III medical device, and imports must be subject to statutory inspections. Untested products should be products that do not meet the statutory requirements. According to the provisions of Article 3 and Article 8 of the “Special Provisions of the State Council on Strengthening the Supervision and Administration of the Safety of Food Products”, the illegal proceeds, products and fines may be confiscated.

Another view is that the examination certificate for high-frequency surgical instruments is complete. As for the problem of test time lag, there are no relevant laws and regulations. Article 15 of the "Measures for the Supervision and Administration of Imported Medical Devices" stipulates that imported high-risk medical devices shall be inspected and managed in the following manner: (1) In the case of import of a class I importer, the combination of on-site inspection and supervision and inspection shall be implemented, and the annual batch The on-site inspection rate is not less than 50%. (b) If importing of Class II or Class III import units, on-the-spot inspection of batches shall be implemented. Therefore, if the import unit is a type, there is no need for batch inspections. The high-frequency surgical treatment instrument used in this hospital only needs to pass the same batch and can be regarded as qualified.

After careful discussion, the law enforcement officers finally determined that the "combined cervical three-in-one system for diagnosis and treatment of cervix" used by the hospital was a device that was not registered with the whole machine and recognized as a qualified product for imported high-frequency surgical instruments. According to the "Regulations on the Supervision and Management of Medical Devices," Article 26, paragraph 3, "Registration of Medical Devices," Article 28 (2) and other provisions of the fine and confiscation of illegal income, and recommended that hospitals stop using the above medical devices.

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Increase law enforcement to curb private assembly

In recent years, with the rapid development of the medical device industry, various new types of medical devices have emerged in an endless stream. However, there are many new products that are assembled from several devices in a self-assembled manner. The security is difficult to guarantee. This is an ordinary product. After simple packaging and finishing, the price is doubled.

In this case, the "triple cervical comprehensive diagnosis and treatment system" is in fact a LEEP knife, but the seller privately grafted colposcopes and surgical fumes to purify the smoker. At present, there is no clear basis for the supervision of this kind of behavior, and sellers do not want to register the whole machine but also want to drill the loopholes in the law. Since the product promotion manual and the operation table are all marked as "the cervical three-in-one system for comprehensive diagnosis and treatment," they should provide a registration certificate for the system. The law enforcement officers investigated the case in accordance with the relevant provisions of the current "Regulations on the Supervision and Administration of Medical Devices". The author thinks it is appropriate. If the relevant laws and regulations can further clearly define the above-mentioned behaviors and supplement the penalty basis clauses, the law enforcement efforts will be even greater, and unauthorized assembly will be effectively curbed.

Regarding the legality of imported high-frequency surgical instruments in this case, it should have been a breakthrough point for the case. Law enforcement officers did indeed think of a lot of ways to find out what was going on. However, subject to objective factors, they had to comply with the "suspects". The principle that sin never exists is to identify products as legitimate products.

In recent years, a large number of imported medical devices have flooded into China. Due to the lag in relevant laws and regulations, these medical devices are still under regulatory vacuum. Therefore, the author appeals to the relevant departments and importing enterprises to strictly implement the system for the admission and filing of imported medical device equipment and establish a system of key supervision and return visits to medical devices and equipment as soon as possible. The pre-entry risk assessment of some imported medical devices will be conducted. Enterprises that do not meet the conditions may implement risk warning systems and "black list" systems.