Cut down many conditions of operating business on medical equipment

It will strengthen the post-inspection on the quality of medical equipment in order to detect and handle wrongdoings, ensuring patients' rights. Photo: Thu Ha

More advantages for enterprises

On 10/5, Medical Equipment and Constructions Department, the Ministry of Health organized a conference of evaluation after 2 years of implementation and deployment of Decree 36/2016/NĐ-CP on medical equipment management, as well as taking comments regarding to content of a draft Decree on amending Decree 36/2016/NĐ-CP on medical equipment management.

According to Nguyen Minh Tuan, Decree 36/2016 / ND-CP is a document issued to unify virtually all issues related to medical equipment from the stage of production, clinical trials, circulation, traceability, trading, inspection, export, import...

According to the Director of Medical Equipment and Constructions Department, in order to implement Decree 36, the Ministry of Health has created a close cooperation and exchange of management information among related ministries and agencies, such as General Department of Vietnam Customs, the Ministry of Finance, customs offices at border gates, units of Health sector in the management of medical equipment, and creating a fair environment as well as facilitating enterprises’ operation in the field of medical equipment.

Accordingly, the processing time for administrative procedures is fast, convenient for the processing, monitoring and management of profile information for enterprises, because all the work is processed on the online system and at level 4 in information technology.

Although there are many advantages, according to the leader of the Medical Equipment and Constructions Department, there are still many difficulties in implementing Decree 36. Accordingly, due to the number of legal documents related to large medical equipment, it is difficult to carry out specific characteristics, complex, frequently changed and more boundaries, related to many sectors of other ministries, while the management of state management tasks in the Ministry of Health is still limited, so many tasks must be performed at the same time, thus affecting the quality and progress of the work. Also, many management contents have not been issued fully yet.

In addition, the coordination of the Ministry of Health with the Health Department in the work of inspection, although the program has been implemented, there are only the two large cities of Hanoi and Ho Chi Minh City that have been deployed.

"Not to mention, many legal documents related to adjustments to the field of medical equipment are often changed and bordering, overlapping between sectors, ministries and sectors causing difficulties in public management. Some contents stipulated in Decree 36 have not been specified, causing difficulties in inspection and checking. The software system is not complete with perfect features for management such as search, retrieval, reporting data on request," Director of Department of Medical Equipment and Constructions Department admitted.

On behalf of the business side, Ms. Pham Thi Thu Ha, Siemens Vietnam Company, representative of the Eurocham businesses said that the many advantages for businesses issued by Decree 36 have created momentum to promote and integrate with the country. However, during the implementation of the Decree, there are still some difficulties. Specifically, the management of a number of medical devices is implemented in parallel with drugs so it causes difficulties for the businesses. Some other companies also question about the time to respond to the dossiers of enterprises on the national single window portal system.

Reducing on pre-inspection and strengthening post-inspection

According to the director of the Medical Equipment and Constructions Department, counting only on the management of imported medical equipment, the unit has handled from 4,500 to 7,000 dossiers annually. Meanwhile, the personnel performing the duties for the Department of Medical Equipment is only 11 people, including leaders in charge.

However, by implementing the reform of administrative procedures, facilitating enterprises under Resolution 19 of the Government, according to Mr. Nguyen Tu Hieu, officials in charge of registration of medical equipment from the Medical Equipment and Constructions Department and the Ministry of Health, have implemented 6 groups of procedures for publication, registration and online licensing in the Ministry of Health (phase 1 from 1/1/2017 on announcement on full conditions for classifying medical equipment and phase 2 from 1/7/2017 with 5 groups of procedures under Decree 36/2016 / ND-CP).

As of 8/5, according to reports from the Department of Health and tracking the online medical equipment management system, the system has received, processed and returned 10,462 dossiers of enterprises implementing the administrative procedures as stipulated in Decree No. 36/2016 / ND-CP on management of medical equipment, in that the number of dossiers has been announced is 10,327dossiers.

In addition, in order to overcome the above limitations, the Ministry of Health is proposing to amend Decree 36 in the direction of abolishing 11 production and business conditions and amending 24 production and business conditions for medical equipment, including some conditions for importing medical equipment in the direction of facilitating enterprises and setting up a warning system for post-sale to detect unqualified products.

At present, the Ministry of Health is coordinating with the General Department of Vietnam Customs and the Ministry of Finance, to draft a circular promulgating a list of poor medical equipment according to the HS code on the list of import and export goods subject to specialized management of Department of Health.

Moreover, Mr. Nguyen Minh Tuan said that in order to control and improve the quality of medical equipment operation, in addition to facilitating enterprises, the Ministry of Health also proposed to strengthen post-inspection in the field of medical equipment. Accordingly, in the past they would implement a pre-inspection that caused long storage times. Nowadays, the post-inspection will be promoted and released on time for enterprises so that the enterprises could be inspected at their production base.

"The post-inspection will be carried out by the testing center. However, this system is still weak, thus it needs to be promoted. The hospital itself, when bidding or procuring, should also be responsible for the inspection and post-inspection when installing for usage, " Mr.Tuan said.

Mr. Nguyen Anh Quang, Head of Financial Department, Hanoi Health Department, through the inspection, the errors of enterprises are mainly violated by personnel for the production and operation without complying to regulations; Operating at the wrong address as stated in the business registration certificate; Trading chemicals and medical equipment as well as testing without Vietnamese labels as prescribed; insufficient documents proving the origin or organization for introduction of medical equipment without permission of the State management authorities; premises and business conditions have not met requirements...

In order to strictly manage the production and trading of medical equipment, according to Mr. Quang, the Hanoi Health Department has promoted the application of information technology to management. However, the implementation is still facing difficulties. In particular, currently, there are no regulations on periodical calibration of medical equipment being used at health facilities whether from domestic production or imported products. Also, there are no specialized authorities on quality inspection of medical equipment.

"In the future, the Health Department will continue to strengthen the inspection and examination of enterprises operating and manufacturing medical equipment. At the same time, the Health Department proposed to the Ministry of Health to promulgate as soon as possible the regulations on the management, maintenance, periodical quality control of medical equipment, amend the Decree on sanctioning of appropriate medical equipment with the current situation, " Mr.Quang said.