2. Objectives of the assignment / Scope of services
Nowadays, there is no unified register of medical devices in Ukraine. Instead of the register of medical devices, a register of medical equipment of manufacturers is maintained.
Recording of information on persons who place medical devices on the market is carried out by the State Service of Ukraine on Medicines and drugs control (hereinafter – SMDC) based on notifications from applicants declaring certain classes of medical devices. In addition, there are approximately 15 conformity assessment institutions that issue certificates for certain categories of medical devices. This information is published on their official websites and submitted to the SMDC.
The lack of a single register of medical devices leads to the impossibility of harmonizing the legislative field with the European Union, which becomes very important after the President of Ukraine signs an application for EU membership. The procedure for adding information on medical devices does not allow the integration of such data into other software products, including those used to implement the electronic inventory management system of medicines and medical devices “eStock”, because there are no unified requirements for the amount and quality of information to be provided.
The ultimate goal of this assignment is to create the grounds for development of a national State medical devices register (SRMD) system, a single information space for data exchange and interoperability between all participants in the process related to medical devices at all stages of their life cycle – from applying for registration to market control. The implementation of this task involves the development of a single unified approach to adding information about each medical device, the use of common interfaces, reference books, and standards of work. The system should be implemented as a centralized register of medical devices with central database and integration with all medical information systems.
The main objective of this assignment is to conduct business analysis for processes connected with the SRMD in part of medical device certification process, device registration process, and social reimbursement process.
3. Description of responsibilities / scope of work
The Consultant will be responsible for conducting the following activities in order to achieve the overall goal of the assignment:
- Conducting interviews with stakeholders in frames of their current functions, further functional requests and potential user-experience.
- Review and analyse national and international legislation which regulates end-to-end processes for the system.
- Work with stakeholders to define business processes, stakeholder needs and their flow.
- Describe and analyse “as is” business process.
- Suggest and describe “to be” business process for the Register target model.
- Compilate requirements, description of back-end logic.
- Provide recommendations for the legal changes of the Register’s and related processes regulation.
- Estimation of projects cost using appropriate systems, tools, and techniques.
- Planning and prioritizing projects backlog and development for the systems.
- Compilate technical requirements for development of the Register as procurement documentation.
- Support preparation of procurement procedures (if necessary).
4. Measurable outputs of the work assignment/deliverables
It is expected that the National consultant to provide business analysis services for “State medical devices register” Project will deliver the following services (non-exhaustive list):
Deliverable # |
Deliverable essence |
Deadline* |
Deliverable #1 |
Analysis of EU Regulations: Regulation (EU) 2017/746, Regulation (EU) 2017/745 in frame of Register functioning. Expected result: Developed regulations overview document which covers medicinal products:
|
In 20 working days after signing the contract |
Deliverable #2 |
Overview of SRMD logical data model and functional structure. Expected result:
|
In 20 working days after acceptance of Deliverable 1 |
Deliverable #3 |
Function requirements for SRMD in part of reimbursement needs and integrational requirements. Expected result: Developed technical requirements which cover medical devices reimbursement needs, include all sub-register’s related to meddevices reimbursement program:
The technical requirements must be agreed with MOH and UNDP |
In 20 working days after acceptance of Deliverable 2 |
* The consultant should provide his/her proposal regarding the quantity of working days needed for each deliverable, based on the tentative deadlines indicated above, and indicate in the financial proposal amount distribution by deliverable section.
4. Management arrangements
The National consultant to provide business analysis services for the development of a state medical devices register will be primarily responsible for achieving the objectives of the assignment. He/ She will be responsible for all personal administrative expenses associated with the assignment.
5. Monitoring requirements / Terms of payment
The National consultant to provide business analysis services for the development of a state medical devices register will work under the overall supervision of the DIA Project Manager and will work closely with DIA Support Senior IT Specialist and Project Manager/Product Owner of the “SRMD” Project from the Ministry of Health of Ukraine (MOH) side.
All deliverables shall be approved by UNDP in written form through e-mail after consultations with MOH representatives. No documents should be published or distributed to third parties without the approval of MOH and/or UNDP. The title rights, copyrights and all other rights whatsoever nature in any material produced under the provisions of this TOR will be vested exclusively in UNDP.
All documents should be submitted to the UNDP in electronic form (*.docx, *.xlsx, *.pptx, and *.pdf or other formats accepted by UNDP). The language of the materials and reports is Ukrainian.
UNDP will provide payment upon provision of each deliverable duly certified by UNDP in accordance with the schedule below:
Deliverable 1. 33%
Deliverable 2. 33%
Deliverable 3. 34%