Removing problems in classification of medical equipment

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Mr. Nguyen Minh Tuan spoke at the Conference. Photo: DN

Medical equipment must be classified accurately

On May 30, the Department of Medical Equipment and Health Works organized a conference to disseminate Decree 36/2016/ND-CP and Decree 169/2018/ND-CP dated December 21, 2018 on the management of medical equipment classification.

Director of the Department of Medical Equipment and Health Works, Nguyen Minh Tuan, said that the country currently has 15,000 categories of medical products, each product has different risk levels and has no limit on the production materials or the intended use.

Therefore, the better management of medical equipment requires a clear classification of risk levels based on building a list of medical equipment with regular updates, ensuring feasibility and convenience for enterprises and strengthening state management on medical equipment.

Mr. Tuan said to manage medical equipment, at the end of 2016, Government Decree 36/2016/ND-CP on management of medical equipment was issued with the expectation of building a synchronous and unified management system nationwide to manage issues related to medical equipment, from production, circulation, import-export, trade, consulting services, to quality control such as standard assessment, traceability and management of post-sale.

In particular, Decree 36/2016/ND-CP is a legal framework for management agencies, hospitals, health establishments and enterprises to clearly understand regulations, rights, responsibilities and obligations when participating in the field of medical equipment, contributing to ensuring the quality, safety, efficiency of the investment and efficiency of the use of medical equipment and improving the quality of medical services, improving the quality of people’s health care and protection .

However, Tuan said, the management of medical equipment under Decree 36/2016/ND-CP raises many problems to be amended and supplemented. Therefore, in 2018, Decree No. 169/2018/ND-CP was issued, helping traders, producers and providers of medical equipment and managers at all levels as well as leaders of hospitals and medical establishments to clearly define their responsibilities, rights and obligations to perform their duties, contributing to ensuring quality, safety and efficiency of investment and use of medical equipment.

The implementation of Decree No. 169/2018/ND-CP will give the field of medical equipment an opportunity to develop, integrate and establish a healthy, quality, safe, efficient and transparent business environment of medical equipment.

Although the management documents of the State agencies are quite suffiecient and strict, the leaders of the Department of Medical Equipment and Health Works together with the Department's officers also drastically implemented measures to manage and provide maximum support for businesses in the medical field, there are still many shortcomings present in the classification of medical equipment of agencies in charge of the classification, making it difficult in terms of management.

Specifically, there was inaccurate classification due to subjectiveness and lack of knowledge or deliberately inaccurate classification for personal purposes.

"There is a situation that products are medicine but are classified as medical equipment or food to get rid of some strict regulations in the pharmaceutical field," Tuan said.

Besides, medical equipment is currently divided into 4 types – A, B, C, D – with different levels of risk. Specifically, medical equipment type A is considered the least risky, while type D is at the highest risk level.

"If the classification is not accurate, medical equipment from type D is classified into B, C or A, it will be very dangerous in use, affecting healthcare for people," Mr. Tuan said.

In addition, Tuan added that there was a situation that the classification results were announced in the morning but were cancelled in the afternoon. There was also a situation that units were dishonest in registering eligibility for classification of medical equipment. This has a significant impact on the management policy on medical equipment of the State management agencies.

Comprehensive solutions

Tuan said that in the furture, the Department will introduce specific solutions and require enterprises to strictly abide by Decree 169 on management of medical equipment.

In addition, to strengthen the inspection and handling of administrative violations in the field of medical equipment, the Ministry is making a Draft to amend and supplement Government Decree 176/2013/ND-CP; building the IT operation process, implementing the issuance of certificates of classification practice of medical equipment and receipts of announcement of classification records of establishments.

"The Ministry of Health will regularly inspect and handle violations (if any) of the units in charge of classification and medical equipment enterprises to create a transparent and equal development environment among enterprises," Tuan said.

On the enterprise side, Tuan noted, enterprises need to seriously implement the regulations of the State management agencies on medical equipment such as the conditions for production, business, and classification of medical equipment and certificates of practice; and are responsible for the legality of announced documents, classification results; will be handled by State management agencies according to the law.

"In addition, enterprises must strictly implement the disclosure of classification results of medical equipment on the Ministry of Health's portal before July 1, 2019 in compliance with Article 68 of Decree 169," Mr. Tuan said.

At the Conference, specialist of the Department of Medical Equipment and Health Works Pham Trung Kien highlighted new points of Decree No. 169/2018/ND-CP.

Specifically, Decree 169/2018/ND-CP supplements the regulation on cases allowed to be adjusted information in the announcement records, creating favorable conditions for enterprises and the Department of Health in management; supplements the regulation on cases quickly granted circulation registration numbers; amends and supplementsthe regulation on requirements for management of post-sale medical equipment and handling medical equipment with errors when circulating in the market.

Decree No. 169/2018/ND-CP stipulates that domestically produced medical equipment had a certificate of circulation registration, the issued circulation number is valid until the end of the time on that certificate. For certificates expired after the effective date of Decree No. 169/2018/ND-CP and before December 31, 2019, they shall be valid until the end of December 31, 2019.

In addition, Decree No. 169/2018/ND-CP also supplements regulations on quick issuance of circulation registration numbers; amends and supplements regulations on requirements for management of medical equipment after sales and handling medical equipment with errors circulating in the market.

Kien said, Decree No. 169/2018 / ND-CP provides many favorable contents for medical equipment importers. Specifically, the Decree stipulates that import permits of medical equipment type B, C and D issued in 2018 expire on December 31, 2018 and import permits issued in 2019 shall be valid until December 31, 2019.

Medical equipment type A, which has a receipt of records for standard announcement issued by the Department of Health, is allowed to be imported according to demand without quantity restriction and without certificate of medical equipment by the Ministry of Health for clearance.

It is expected to continue cutting some administrative procedures related to medical equipment

Medical equipment out of the list of items subject to import permits and classified into medical equipment type B, C and D is allowed to be imported until December 31, 2019 according to the demand without quantity restriction and without certificate of medical equipment by the Ministry of Health for clearance.