July 19, 2019 05:15

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

09:26 | 25/11/2018

VCN - The Ministry of Health is accelerating the implementation of the National Single Window mechanism for handling administrative procedures for people and businesses. It is expected to simplify, cut 72% of the conditions on investment, business and administrative procedures in the health sector.

it is expected to continue cutting some administrative procedures related to medical equipment Will over 1,500 business conditions in medical field be abolished and amended?
it is expected to continue cutting some administrative procedures related to medical equipment Why has the Ministry of Health not connected NSW with medical equipment type B, C and D?
it is expected to continue cutting some administrative procedures related to medical equipment Most medical equipment in Vietnam is imported
it is expected to continue cutting some administrative procedures related to medical equipment
Particularly, the equipment has 15,000 kinds of products with different levels of risk.

Efforts for administrative reform

At the consultation seminar on the report on assessment and review of administrative procedures in the field of medical equipment on November 21st, 2018, Mr. Ha Anh Duc, Deputy Head of the Ministry of Health’s office said that the Ministry of Health has attempted to reform administrative procedures, simplify procedures in the specialized inspection, particularly in food safety, reducing by 810/815 procedures, accounting for 98% of the total imported food shipments which are not subject to specialized inspection at border gates, but are subject to post-clearance and post-marketing inspections in accordance with the application of Decree No. 15/2018 / ND-CP.

Mr. Duc added the Ministry of Health is setting up and operating an administrative service to speed up the implementation of the National Single Window mechanism in handling administrative procedures for people. At the same time, accelerating the application of online public services at level 4; particularly, reducing 72% of conditions on investment, business and administrative procedures in the health sector, including the amendment and supplementation of some articles of Government Decree No. 36/2016 / ND-CP on medical equipment management.

However, he also admitted that some administrative procedures still affect the efforts of the Health sector in resolutely creating a favorable business environment. The handling of dossiers is delayed and over the time limit. There is a lack of communication in handling administrative procedures.

Mr. Duc assumed that this situation is because during the development of institutions, legal documents and law, the consultation with related parties as well as assessment of impact of administrative, business conditions and list of goods subject to specialized inspection were not focused.

Particularly, only medical equipment has 15,000 kinds, each of which has different levels of risk, is not limited to production materials and is not designated for use purpose. Hence, good management of medical equipment requires a clear classification of risk levels based on development of medical equipment lists which should be updated regularly to ensure the feasibility and facilitation to businessess, and to strengthen the State management on the medical equipment.

Resolutely prevent the raising of sub-licenses

From the reality, Mr. Nguyen Minh Tuan, Director of Department of Medical Equipment and Health Works under the Ministry of Health, said that the Ministry has held many seminars to consult State management agencies such as General Department of Customs and enterprises on the amendments and supplements of Decree No. 36/2016 / ND-CP, which is expected to be submitted to the Government by the end of November, 2018.

According to Nguyen Minh Tuan, the general objective of this decree is to minimize administrative procedures, to create the most favorable conditions and resolutely prevent the raising of sub-licenses.

Regarding new points of administrative procedures and management in the draft Decree amending Decree No. 36/2016 / ND-CP, according to Pham Trung Kien, Department of Medical Equipment and Health Works: This Decree shall amend and supplement provisions related to medical equipment and raw materials for the production of medical equipment containing narcotic substances and pre-substances on the principle of meeting provisions of this Decree and complying with provisions of Law on drug prevention and fight.

In addition, the Decree also adds procedures for the issuance of practising certificate for classification of medical equipment so as to enhance the quality management of the classification, because this is the first step and is a decisive factor for the quality management. At the same time simplifying the procedures for disclosure of eligibility for medical equipment classification. It requires only one condition and only one person having a practising certificate for medical equipment classification.

This revised Decree is also to simplify the procedures for disclosure of eligibility of medical equipment production in the direction of eliminating the conditions of infrastructure, equipment and personnel, but only requiring the application of quality management system ISO.

At the same time, the draft Decree also supplements the cases which are granted circulation number in a short time, within 30 days since the date of receiving the application including 2 cases.

The first case is that the medical equipment which has been granted a free circulation certificate from at least two countries or organizations as below: the EU Member States, Japan, Canada, TGA of Australia, US FDA and circulated in a minimum of 2 consecutive years at the time of submission of the application for new circulation number;

The second case is that medical equipment was granted import license or circulation certificate before December 31st 2019, and supplied and used at health facilities through contracts executed within at least 2 years prior to the time of submission of the application for new circulation number without being warned about the quality and safety in the use process.

A new point of this draft Decree, is that medical equipment types B, C, D are not on the list of import permits to be continued import until December 31st 2019, without confirmation by the Ministry of Health for customs clearance.

In addition, in this draft Decree, the Ministry of Health stipulates that medical equipment products for in vitro diagnostic that have been granted a circulation certificate in accordance with the provisions of the Pharmacy Law 2005 and its guiding documents, the granted circulation number is valid until the time shown on the circulation certificate. Particularly for product circulation numbers for in vitro diagnostic which are invalid after January 1st, 2019, and before December 31st, 2019, are allowed to use until December 31st, 2019.

it is expected to continue cutting some administrative procedures related to medical equipment Results for a series of imported medical equipment classifications have been changed

VCN - According to the Customs Newspaper’s source of information, during the past, many enterprises having the function ...

Regarding licenses for import, export and temporary import for export, under the draft Decree, for cases requiring import licenses, in addition to 8 conditions described in Decree 36, enterprises must meet the requirements on operational software of medical equipment which is firstly imported to Vietnam, excepting the case where the software has been integrated with medical equipment and the case where the software has been granted import license or integrated with medical equipment which has been granted circulation certificate or import license.

For the provision on exemption for inspection for the first time before putting medical equipment in to use, the Ministry of Health stipulates that medical equipment shall be exempted from inspection for the first time before being put into use if they fall into one of the following cases: Medical equipment has been granted technical regulation certificate; imported medical equipment has not been granted circulation certificate for purposes of scientific research or testing or training, guidance on the use, maintenance and repair of other medical equipment; and imported medical equipment has not been granted circulation number for individual health treatment of the importer, or for the purpose of humanitarian health examination, or for special diagnostic needs.

By D. Ngan/ Huyen Trang