In an effort to map the value of the Domestic Content Level (TKDN) in domestic medical device products, the Directorate of Pharmaceutical Security and Medical Devices of the Directorate General of Pharmaceuticals and Medical Devices of the Indonesian Ministry of Health, held a Focus Group Discussion (FGD) with cross-sectors, in a hybrid manner in Jakarta on Monday (17/7).
This activity aims to identify and map the achievements and implementation of TKDN certification of medical device products (alkes) circulating in Indonesia in order to support the development of the domestic medical device industry.
Lupi Trilaksono, Head of the Working Team for the Improvement and Facilitation of TKDN of Medical Devices and the Use of Domestic Medical Devices, Directorate of Pharmaceutical and Medical Device Resilience, said that this meeting was a series of meetings related to the implementation of regulations on the use of domestic medical devices, especially regarding the implementation of the Domestic Component Level (TKDN) policy.
"From this activity, it is expected to identify and evaluate the achievement of TKDN certification of medical equipment and also efforts for future improvement as a material for compiling what interventions can be made by the government as a regulator and the private sector as a producer of medical equipment," he added.
The meeting was attended by representatives from the Ministry of Industry, PT Surveyor Indonesia, PT Sucofindo, the Indonesian Medical Device Manufacturers Association (ASPAKI), the Organization of Medical Devices and Laboratories Companies (GAKESLAB Indonesia), the Indonesian Medical Gas Installation Association (AIGMI) and domestic medical device industry players.
Director of Pharmaceutical and Medical Device Resilience Roy Himawan in his remarks, said that in order to support the Transformation of the Health Resilience System, the Ministry of Health has made policies to encourage pharmaceutical and medical device resilience, especially medical device resilience, in the form of guaranteeing the market which is carried out, among others, substitution of imported products.
"If domestic medical equipment products are similar to imported medical equipment products with the same specifications that can be produced domestically and meet national needs, then a freeze on imported medical equipment products will be carried out," he said.
This is in accordance with the Decree of the Minister of Health Number HK.01.07/MENKES/1258/2022 concerning the Substitution of Imported Medical Devices with Domestic Medical Devices in the Health Sectoral Electronic Catalog.
Roy further said that transaction data in the e-catalog shows an increase in domestic medical equipment spending from 2.3 T (12 percent) in 2019-2021 to 10 T (34 percent), in 2022 until as of July 10, 2023 medical equipment spending on domestic products amounted to 8.8 T (48.2 percent).
"This progress is quite encouraging, but the prioritization of domestic medical equipment purchases must continue to be improved," he said.
Roy also said that the Ministry of Health has conducted regular monitoring of the number of medical device products certified with TKDN above 50 percent. Based on e-catalog data, as of June 30, 2023 there were 6,782 (24.9 percent) e-catalog medical device products that had TKDN certificates above 50 percent.
"The Ministry of Health and the Ministry of Industry are synergizing to continue to increase the number and types of domestic medical devices including the increase in domestic medical devices that are TKDN certified. Thus, the development of the medical equipment industry must continue to be encouraged to meet the needs of domestic medical equipment," he added.
This meeting should be able to provide data and an overview of the achievements of TKDN certification of medical devices and the obstacles experienced in obtaining TKDN certification of Medical Device products as material for determining appropriate interventions from the government as a regulator and the private sector as a business actor.
"I hope this meeting is useful so as to encourage and facilitate the domestic medical equipment industry to increase the TKDN value of medical equipment products and quality, and ultimately increase the use and purchase of domestic medical equipment in the implementation of government procurement of goods / services," he added.
On the same occasion Arthur Sopar from the Center for the Acceleration of the Use of Domestic Products (P3DN), Ministry of Industry said that based on Minister of Industry Regulation No. 46 of 2022, the Government is freeing and facilitating the TKDN certification process for small industries (TKDN IK), so that they can participate in PBJP and become a priority for purchase, and get price preferences.
"There are three advantages obtained for TKDN IK, the first is easy because the TKDN IK certificate is self-assessment and can be printed independently, the second is fast because the TKDN IK certificate is authorized within a maximum of five working days and the third is free or the certification process is free of charge," he added.
Meanwhile, Achmad Taufik from the Ministry of Health's Procurement Bureau said that the priority of using PDN in the E-Purchasing process according to the Decree of the Head of LKPP Number 122 of 2022 is if there are domestic products (PDN) with a TKDN value and a Company Benefit Weight (BMP) of at least 40 percent, then what must be purchased is PDN with a TKDN value of more than equal to 25 percent, but if it cannot be fulfilled then buy PDN with a TKDN value of less than 20 percent, if it is still not fulfilled then buy PDN products without TKDN, if it is still not fulfilled then buy imported products.
On this occasion Christina Sandjaya, Secretary General of ASPAKI, expressed her response "We appreciate the government support given to MSMEs, the TKDN certification process for small industries is really made easy, standard certification does not need a field visit or verification, it is fast, easy and free, please also increase supervision, do not let MSMEs make medical devices with high risk and easy to make, high TKDN so that many are bought," she said.