In 2022, the program to strengthen the network of medical device testing laboratories is implemented by the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Medical Device Supervision in order to improve the quality and quantity of medical device testing laboratories for quality assurance of medical device products in the pre and post market. This is also in line with the transformation of the health system which includes increasing the resilience of the pharmaceutical and medical device sectors to support the independence of domestic production.

Strengthening this testing laboratory network includes strengthening the Malaria Rapid Diagnostic Test (RDT) product testing laboratory with WHO Pre-Qualification (PQ) standards. Medical device testing laboratories that meet WHO PQ Standards will have a better level of trust and acceptance of the test results produced, both nationally and internationally.

Malaria RDTs belong to a group of in vitro diagnostic medical devices that play an important role in supporting the national malaria program through diagnosis and screening of cases in health facilities, especially in areas that do not have access to microscopic tests. Every year at least 2 million RDTs are used by the national malaria program and currently, the number of malaria RDT products that have distribution permits in Indonesia is 90 products, of which 8 are domestic products and 82 are imported products.

The production, distribution and use of malaria RDTs must be accompanied by a pre-market (pre-market evaluation) and post-market (sampling and testing) supervision system. This supervision is the duty of the Ministry of Health through the Directorate General of Pharmaceuticals and Medical Devices to ensure the safety, quality and benefits of medical devices in circulation as mandated in Law No. 36 of 2009 concerning Health. Adequate testing laboratories in terms of capacity and competence are needed and are a challenge to the needs of the supervision system.

The activity of strengthening the Malaria RDT testing laboratory for WHO PQ is carried out collaboratively between the Directorate General of Pharmaceuticals and Medical Devices, the Directorate General of Disease Prevention and Control, and WHO in order to support the Ministry of Health's national program in the resilience of the medical device industry and malaria elimination.

With the support of WHO, last September 26-29, 2022 an assessment visit was conducted by WHO South East Asia Region (SEARO) consultant Dr. Anupkumar Rameshrao Anvikar, MD on 2 laboratories owned by the Ministry of Health as a candidate for national reference laboratory and WHO PQ for Malaria RDT.

The two laboratories are the Jakarta Environmental Health and Disease Control Technical Center (BBTKL-PP) and Prof. Dr. Sri Oemijati Laboratory. This assessment aims to assess the capacity and competence of the two laboratories in malaria RDT testing according to WHO standards (Lot Testing).

On October 3, 2022, the results of the assessment of capacity and competence of national reference laboratory candidates and WHO PQ for Malaria RDTs by Dr. Anupkumar Rameshrao Anvikar, MD to the Director General of Pharmaceuticals and Medical Devices L. Rizka Andalucia and relevant Cross Program leaders online.

Dr. Anupkumar Rameshrao Anvikar, MD expressed his appreciation to the Ministry of Health for its efforts in developing a national reference laboratory and WHO PQ for Malaria RDTs, which will certainly play a role in quality assurance of Malaria RDT products.

On this occasion, Director General Rizka expressed his gratitude to WHO for supporting and collaborating in efforts to develop a Malaria RDT testing laboratory, especially to WHO SEARO.

"With this national reference laboratory and WHO PQ for malaria RDT, it is expected to support the national malaria elimination program and also support the health transformation program, especially in terms of the resilience of domestic medical device products," said the Director General.