How to Determine If Your Product Is a Medical Device

In practice, whether the product belongs to the medical device is the core issue. The specific judgment needs to be made from the product appearance (label and instruction), product utility approach, expected purpose, medical device meaning and other aspects. For example, medical devices include ring cutters, medical instruments forceps, ophthalmic speculum, etc.

 

 

1. Product Appearance Judgment

The judgment of product appearance mainly depends on the appearance information such as product name, label and instruction book. For example, whether the product name is identified as the medical device, or whether it is marked as the general name of the medical device. For the license registration information, such as whether the product label is marked with the registration number of the medical device manufacturer, the medical device production license number, the medical device product registration number information (category I), and the medical device product registration certificate number information (Category II and III).

 

 

2. Judgment of Utility Approach

The purpose and expected utilization of the medical device can be seen by consulting the technical data such as the label, instruction and operation manual of the product. The utility of medical devices is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although there are these ways involved, they only play an auxiliary role, for example, inflatable speculum, different surgical scissors, eye cannulas surgical instruments, etc.

 

 

3. Judgment of Utilization Purpose

Whether the product category belongs to the medical device or not can be determined by the utilization purpose of the medical device. The purpose of medical devices includes the following aspects.

 

(1) Diagnosis, prevention, monitoring, treatment or remission of diseases

 

(2) Diagnosis, monitoring, treatment, remission or functional compensation of injury

 

(3) Examination, substitution, regulation or support of physiological structure or process

 

(4) The support or maintenance of life

 

(5) Pregnancy control

 

(6) To provide information for medical or diagnostic purposes by examining samples from the human body.

 

 

4. Legal Judgment

The legal judgment mainly includes two parts. That is, whether it belongs to the medical device and what kind of medical device it belongs to.

 

(1) Whether It Belongs to Medical Device or Not

Whether it belongs to medical devices or not is mainly determined according to the meaning of medical devices stipulated in Article 76 of‘the Regulations on the Supervision and Administration of Medical Devices’, for example, frog speculum, different types of nasal cannulas, etc.

 

(2) Determination of Classification

There are three aspects to determine which kind of medical devices it belongs to.

 

① The first is‘the Classification Rules of Medical Devices’, which is clearly stipulated in the appendix of‘Classification Judgment Table of Medical Devices’.

 

② The second is‘the Medical Device Classification Catalogue’.

 

③ The third is the stipulations of Article 17 of‘the Measures for the Registration and Administration of IVD Reagents’.

 

For example, according to‘the Measures for the Registration and Administration of IVD Reagents’, according to the product risk degree from low to high, IVD reagents are divided into the first category, the second category and the third category. If the products are‘coronavirus (2019-nCoV) nucleic acid detection kit’and‘coronavirus nucleic acid detection kit’, they should be managed according to Class III medical devices.

 

Medical devices and medical consumables are also different. Medical devices include air injection cannula, medical suture scissors, etc., while medical consumables are just a conventional term commonly named by medical professionals, which generally refers to disposable medical devices, especially some sanitary materials.