Project Summary  

Lao PDR faced serious shortages and price fluctuations in medical supplies during the COVID-19 pandemic and was in a critical need of supply and quality control of medical products in the country markets. To tackle the adverse impacts of the pandemic, with generous funding from the Government of China, UNDP in close cooperation with the Ministry of Health, provided technical support to enhance the domestic production of Personal Protective Equipment (PPE) and a quality management system for PPE production and better market access and control.  

Background 

During the COVID-19 pandemic, Lao PDR faced two major issues. First, the country experienced serious shortages and price fluctuations in medical supplies, as it is largely dependent on imports. Second, the quality of the supply did not match the necessary standards. Indeed, the quality of imported and domestically produced medical devices and supplies varies significantly due to the limited regulation and surveillance capacity. 

Beyond the pandemic, the need for qualitative medical products is critical for the health and safety of medical workers, but also of the general population. As such, in the long run, local production of medical products and quality control in the markets appear as one of the challenges for sustainable socio-economic development. 

Aware of this situation, the Government of Lao PDR aims to promote the local production capacity of high-quality Personal Protective Equipment (PPE) and enhance its regulatory capacity by developing PPE Manufacturing Establishment Guidelines, National Medical Device Registration Regulations, and PPE Inspection Guidelines and tools. 

Project Outcome  

The objective of this project is to enhance the capacity of PPE production and supply in Lao PDR and to increase the quality of medical devices in Lao markets through:  

• Developing National PPE Manufacturing Establishment Guidelines based on the ISO Quality Assurance system to enable local PPE manufacturers to establish high-quality PPE production lines. 
• Enhancing the production capacity of selected PPE at the State Enterprise Pharmaceutical Factory through procurement of production lines and technical support. 
• Establishing a quality management system to ensure the quality of medical devices and supplies available in the markets of Lao PDR. 
• Developing a set of instrumental documents to manage the PPE market efficiently and to refine relevant requirements for manufacturers applying for the appropriate licenses to produce PPE. 

Results and Achievements   

• Introduced a quality management system based on ISO 13485: 2016 & 9001: 2015 and developed PPE Manufacturing Establishment Guidelines. 
• Established good regulatory practices and quality management systems for the National Regulatory Authority.  
• Procured PPE production equipment to promote the production capacity of the state enterprise.  
• Enhanced capacity on PPE quality surveillance 
• Developed and disseminated the ‘National Medical Device Registration Regulation’. 
• Improved post-marketing surveillance and enforcement by building the capacity of provincial Food and Drug Inspectors on the PPE supply chain. 

 GESI Component: 

One of the targeted beneficiary groups for this project is frontline health workers, the majority of whom are women. In Lao PDR, many hospitals have been facing a serious shortage of PPE products due to the unpredictable supply and price fluctuation of imported items. In addition, due to the limited number of hospital beds available in the country and border closures, many of the COVID-19 patients were treated and quarantined at home. Caretakers of these patients at home were predominantly women. 

The increased protection of these professional and non-professional caretakers is an urgent gender issue. Furthermore, the project is expected to benefit the factory workers by providing them with income opportunities, who are also predominantly women. 

Project Details:  

• Status: On-going 
• Start Date: June 2022 
• End Date: August 2024 
• Project Office: Department of Food and Drug (DFD), Ministry of Health (MoH)  
• Focus area: Resilience, Health, Medical Supply Production  
• Implementing partner: Department of Food and Drug (DFD), Ministry of Health (MoH)  
• Donor: Government of China
• Total project budget: 1,207,264 USD  

Contacts:  

Aksonethip Somvorachit  

Communications Analyst, UNDP in Lao PDR  

aksonethip.somvorachit@undp.org   

+856 21 267777  

Daodouangkham Norasinh 

Project Coordinator 

daodouangkham.norasinh@undp.org 

+856 20 29 393 959 

Abduvakkos Abdurahmanov  

Team Leader  

Natural Resources Management, Climate Change and Disaster Risk Reduction Unit  

UNDP in Lao PDR  

abduvakkos.abdurahmanov@undp.org    

+856 21 267777