Our company currently has a product in the form of a nasal spray and is considering an appropriate registration route for market circulation. The company would like to know whether this product can be registered as a medical device.
Answer
1. Can the product be registered as a medical device?
According to Clause 1 Article 2 of Decree No. 98/2021/ND-CP:
“1. Medical device means equipment, implantable materials, instruments, materials, in vitro reagents and calibrators, software that simultaneously meet the following conditions:
- a) Used individually or in combination as instructed by the owner of the medical device for human use for one or more of the following purposes:
- Diagnosis, prevention, monitoring, treatment and alleviation of disease or compensation for injury, trauma;
- Examination, replacement, modification, or support of anatomical structures or physiological processes
- Life support or life maintenance;
- Contraception control;
- Disinfection of medical devices;
- Provision of information for diagnostic, monitoring, or therapeutic purposes through the testing of specimens derived from the human body.
- b) Not using pharmacological, immunological or metabolic mechanisms in or on the human body or if using such mechanisms then only for the purpose of supporting the objective specified at point a of this clause.”
Accordingly, the product in the form of a nasal spray can be classified and registered as a medical device if it simultaneously meets the following two conditions:
- First, the product must be used for a medical purpose, for example diagnosis, prevention, treatment or support for functional rehabilitation.
- Second, the product does not operate through pharmacological, immunological or metabolic mechanisms on the human body, or if it does then such mechanisms are only for support purposes.
Therefore, the company needs to provide the composition, intended use and documents proving that the nasal spray product meets the two conditions above.
2. How is the product classified as a medical device?
According to Article 4 of Decree No. 98/2021/ND-CP (amended and supplemented by Clause 7 Article 147 of Decree No. 96/2023/ND-CP) providing:
“Medical devices are divided into 4 categories based on the level of potential risk related to the technical design and production of such medical devices:
- Medical devices classified as Class A are medical devices with low risk.
- Medical devices classified as Class B are medical devices with low to moderate risk.
- Medical devices classified as Class C are medical devices with moderate to high risk.
- Medical devices classified as Class D are medical devices with high risk.”.
Based on Rule 5 of Annex I of Circular No. 05/2022/TT-BYT providing:
“Rule 5. Classification of medical devices inserted into body orifices without surgery
- Medical devices inserted into body orifices without surgery, not used for connection to active medical devices or only connected to Class A medical devices are classified as Class A if used temporarily. In case such medical devices are used on the surface of the body, the eyeball or are absorbable by mucous membranes they are classified as Class B.
- Medical devices inserted into body orifices without surgery, not used for connection to active medical devices or only connected to Class A medical devices are classified as Class B if used for a short period. In case such medical devices are used in the body region from the oral cavity to the pharynx, from the auditory canal to the eardrum or in the nasal cavity they are classified as Class A.
- Medical devices inserted into body orifices without surgery, not used for connection to active medical devices or only connected to Class A medical devices are classified as Class C if used for a long period. In case such medical devices are used in the body region from the oral cavity to the pharynx, from the auditory canal to the eardrum or in the nasal cavity and are not absorbable by mucous membranes they are classified as Class B.
- All medical devices inserted into body orifices (excluding those inserted surgically) used to connect to an active medical device of Class B or higher are classified as Class B.”
Pursuant to Clause 6 Article 5 of Decree No. 98/2021/ND-CP (amended and supplemented by Article 147 of Decree No. 96/2023/ND-CP) also providing that the classification of medical devices must be performed by a classification establishment which is the entity named in the declaration of applied standards or in the registration for circulation.
Accordingly, the classification of the nasal spray product may fall under Class A, B or C depending on usage characteristics, duration of retention in the body and ability to be absorbed through mucous membranes, based on the classification rules in Circular No. 05/2022/TT-BYT. To determine the appropriate medical device class, the company needs to prepare and submit the classification dossier to a qualified classification establishment, which is also the entity named in the declaration of applied standards or in the registration for circulation. Complying with the correct classification process is not only a legal requirement but also helps the company avoid legal risks during the circulation of the product on the market.
