Why has the Ministry of Health not connected NSW with medical equipment type B, C and D?

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Mr. Nguyen Minh Tuan

After more than one year of implementation of the Government's Decree No. 36/2016 / ND-CP on medical equipment management, what are the biggest results that health establishments and enterprises have gained, Sir?

Decree No. 36/2016 / ND-CP of the Government has created a strict legal framework to help managers, hospitals, health establishments and enterprises understand regulations, identify rights and obligations of parties involved in the field of medical equipment.

In Decree 36/2016 / ND-CP, medical equipment is divided into four types A, B, C and D for management. Based on the level of risk for patients, health staff and the community, appropriate management measures will be applied. After a period of implementation, many enterprises responded to the Ministry of Health that the Decree facilitated many aspects, helped them clearly understand mechanisms, rights and obligations in production and business and compliance with the international regulations. Especially, the transformation into form of issuance of registration numbers for circulation of products with 5 year-validity, enterprises can proactively operate or authorize other eligible units when joining bidding on medical equipment supply.

For large equipment companies, the provisions of Decree No. 36/2016-ND-CP comply with international practices, so the implementation are unified in both domestic country and foreign countries. In addition, when a company wants to import products into Vietnam’s market, it only needs to submit a registration number of the products free import without restrictions on the quantity and import times and without import permits as current time. In particular, the Decree also encourages and provides incentives in the production and business of home-made products, specifically policies on land, corporate taxes and sales taxes.

The management of medical equipment is carried out in four types A, B, C and D, but the issuance and validation of registration numbers have just been applied for only type A while types B, C and D have been proposed to the Government for the delay of the deadline to 1st January 2019 instead of 1st Janaury 2018 as prescribed. This proposal has just been approved by the Government, so what will the Ministry of Health do to achieve the highest results in the next year?

After more than one year of implementation of the medical equipment management under Decree 36/2016 / ND-CP, the preliminary assessment of the implementation of the two health departments with a large number of enterprises involved in production and business of medical equipment, which are Ha Noi city and the Ho Chi Minh City, revealed that the Departments implemented the management in their areas well by receiving and launching 3 administrative procedures, receiving and handling applications, and announcing applicable standards to thousands of dossiers of medical equipment type A. For medical equipment types B, C and D, the Ministry of Health has received applications for registration numbers for circulation and has urgently carried out procedures to grant circulation permits for these types in accordance with the regulations on 1st January 2018. However,some problems have arisen during the implementation.

Accordingly, the receipt and assessment of applications and issuance of circulation permits (as stipulated in Article 58 of Decree No. 36/2016 / ND-CP) are carried out online on the software interface and implemented in compliance with the online public service at level 4 and interconnected according to the National Single Window (NSW). This is also the first time that the circulation permits for medical equipment have been issued under the NSW mechanism so the errors arising are unavoidable. Thus, those errors must be corrected to meet the professional requirements, affecting the progress and assessment time of applications for registration numbers.

Moreover, the Ministry of Health has not yet been able to connect online public services at level 4 with circulation registration of medical equipment types B, C and D on the NSW Portal according to the plan committed with the General Department of Customs to meet the requirement on time from 1st January 2018.

Furthermore, during the past, the Ministry of Health has also received many suggestions and recommendations from enterprises as well as business associations: US – ASEAN and EuroCharm in Viet Nam related to the difficulties on insufficient time for preparation of application and notarization of documents as prescribed.

On 11th October 2017, the Ministry of Health received an Official Letter No. 310/2017 / MOH / EUC-MDDSC where EuroCharm mentioned some difficulties that they met during the preparation of applications for circulation registration for medical equipment types B, C and D. Accordingly, the number of products which 15 companies in the EuroCharm Group are trading is more than 40,000 products, corresponding to about 4,000 circulation registration numbers. This is difficult to prepare applications for circulation registration within 4 months. Because the owners can not provide timely information and documents due to the large number of documents and different requirements between countries and staff, who do not meet the preparation of the application due to the large number of documents that need to be translated into Vietnamese language, the preparation of labels and legal documents.

For the above reasons, in order to ensure the stability of the market of medical equipment and not to affect the supply of medical equipment to hospitals and health establishments, and to facilitate enterprises and management agencies to have enough time to prepare applications for the registration numbers for circulation of medical equipment under the Customs NSW mechanism and IT application at level 4, Ministry of Health agreed with the suggestions of the enterprises and proposed the Government delay the issuing time and effective time of circulation numbers of medical equipment types B, C and D to 1^st January 2019, instead of 1^st January 2018 as stipulated in Decree 36/2016 / ND-CP.

To carry out Government's Resolution 131 / NQ-CP in line with the schedule, there will be a lot of work to be done, but with specific work to be drastically done by the Department of Medical Equipment and Construction in the near future, we think that by 1st January 2019, the issuance of circulation number of medical equipment types B, C and D would be smoothly deployed, thus, actively facilitating enterprises and ensuring to prevent the lack of medical equipment for health examination and treatment at health establishments, caused by this reason.

Recently, the safety in using medical equipment has been mentioned many times, especially after the failure of kidney dialysis in Hoa Binh General Hospital. Many people think that this was due to error of the system, what do you think about this and what will the Ministry do to ensure the safety in using medical equipment?

To manage medical equipment under the instructions of the Minister and leaders of the Ministry of Health, Department of Medical Equipment and Construction, they continue to inspect and direct the hospitals in the country to seriously study and follow the provisions of Decree No. 36/2016 / ND-CP on management of medical equipment. In which, the points and contents clearly stipulate the roles and responsibilities of concerned parties in the management of use of medical equipment.

The Ministry of Health has also sent official letters to the People's Committees and the Health Departments of the provinces and cities under the Central Government to request for enhancing inspection of management of investment, exploitation and use of medical equipment; and also directly inspected some health establishments and hospitals. At the same time, the Ministry held many conferences, seminars and training for 63 provinces, cities and their subordinate units to disseminate law and rectify activities of investment, management, exploitation and use of medical equipment over the country.

Because the medical equipment is very diverse, has various types, features and functions, and allocated to many management agencies, it is necessary to have a close coordination of concerned parties in the investment management, operation, inspection and assessment to obtain the best results. It is also necessary to realize the responsibility in ensuring the quality of medical equipment in general and the responsibility in ensuring the safety in the operation and use for patients in particular.

Most medical equipment in Vietnam is imported VCN – The Medical Equipment and Construction Department, Ministry of Health held a conference to disseminate and ...

The fact that the safety of medical equipment depends on many factors. Besides the factors of origin and quality, the safety of patients depends much on management at the health establishments and hospitals, such as by promulgation, inspection, supervision and compliance with regulations. Also, professional procedures and quality management of each health establishment, the qualifications and experience of technical staff, and staff in charge of the use and management, conditions on installation and operation, and maintenance of medical equipment. If all stages are carried out well, the safety of medical equipment will achieve the highest results.

Thank You, sir!