VCN - Silnozigyn vaginal capsule and SIMICARBO tablets are imported by enterprises with a classification of medical equipment. However, the customs agency suspects that this is an act of importing drugs disguised as medical devices.
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According to Hai Phong Customs Department, in the past, some enterprises imported Silnozigyn vaginal capsules and SIMICARBO tablets and declared them as medical equipment.
|Silnozigyn capsules are advertised for sale by many pharmacies (not medical equipment facilities). Source: Internet.|
At the time of importation, the company presented a classification of medical equipment. However, on checking import documents, Hai Phong Customs Department discovered inconsistencies. Specifically, in the instruction manual in the box packed with SIMICARBO tablets, there are descriptions and usage. "Each SIMICARBO box contains 20 2-layer tablets. SIMICARBO tablets are very useful in reducing stimulant symptoms related to swallowing and intestinal distention, therefore, the product is recommended for the treatment of stomach-related flatulence (swallowing) or intestinal bloating due to gas accumulation, reducing pain, muscle cramps and prevents flatulence, belching."
Each tablet contains 50mg Simethicon, Carbon 300mg and other excipients.
|Pharmaceutical Law (2016) stipulates: Drugs are preparations containing pharmaceutical substances or medicinal materials for human use for the purpose of preventing diseases, diagnosing diseases, treating diseases, reducing diseases, regulating human physiological functions including pharmaco-chemical drugs, medicinal herbs, traditional medicines, vaccines and biological products.|
The effective mechanism of SIMICARBO is due to the anti-foaming activity of Simethicon combined with the carbon absorption activity.
Double-layer tablets release approximately 50% of the components into the stomach environment within 15 minutes and completely in the intestinal environment within 1 hour.
The dosage for adults is 4 capsules daily, preferably 2 tablets after each main meal.
According to Hai Phong Customs Department, based on the current regulations (Decree 169/2018 / ND-CP) the classification of medical equipment is carried out by classification agencies at the time of importation, expenditures Department (where the enterprise opens the declaration) is based on the results of classification of medical equipment (of classifying establishments) to settle procedures as prescribed.
However, according to Hai Phong Customs Department, compared with the concept of distinguishing pharmaceuticals and medical equipment today, SIMICARBO tablets have many suitable classification characteristics as pharmaceuticals (medicines).
Therefore, Hai Phong Customs Department assesses risks in taking advantage of importing drugs but declaring them as medical equipment.
There have been many cases of misclassifying medical equipment
Regarding this issue, on April 9, the reporter spoke with an official from the Department of Medical Equipment and Facilities (Ministry of Health). In the opinion of this person, the above products mentioned by Hai Phong Customs are medicine, not medical equipment, because they contain excipients.
As mentioned above, the classification of medical equipment is carried out by organizations (in accordance with Decree 169 and Decree 36/2016 / ND-CP).
In fact, it is not always possible to classify equipment by these organizations.
At the end of 2018, the Customs newspaper published a series of articles "Unusual batches of imported medical device classification results were changed".
According to documents and surveys of Customs Newspaper, at that time, many enterprises (organizations) with the function of classifying medical equipment continuously announced changing classification results for imported goods due to incorrect classification
Working with the reporter of the Customs Newspaper in November 2018, Mr. Nguyen Minh Tuan - Director of the Department of Medical Equipment and Works (Ministry of Health) admitted that there is a classification system that has not studied the rules carefully. Classification should issue false classification results. In particular, there is a classification system that deliberately falsifies the results of classification of medical equipment.
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Facing the situation, the Ministry of Health has developed and submitted to the Government for promulgation Decree 169 to amend and supplement some articles of Decree 36 to prevent and effectively handle violations related to classification of medical equipment.
Decree 169/2018 / ND-CP stipulates:
Medical equipment are types of implements, instruments, materials, implants, reagents and in vitro calibrators, software that meet the following requirements simultaneously:
a) Used alone or in conjunction with the designation of a medical device owner to serve people for one or more of the following purposes:
- Diagnose, prevent, monitor and treat and reduce illness or compensate for injuries and injuries;
- Check, replace, adjust or support anatomy and physiological processes;
- Support or maintain life;
- Control conception;
- Disinfect medical equipment, including chemicals used in the testing process;
- Provide information for the diagnosis, monitoring and treatment through measures to check samples derived from the human body. Not using pharmacological, immunological or metabolic mechanisms in or on the human body or if using these mechanisms, it is only supportive to achieve the purpose specified at Point of this Clause.
b) Not using pharmacological, immunological or metabolic mechanisms in or on the human body or if using these mechanisms, it is only supportive to achieve the purpose specified at Point of this Clause.
By Thai Binh/ Bui Diep