Head of Indonesia Ministry of Health, Nila Moeloek, said that the Ministry is trying to accelerate medical device and household products licensing by developing Single Submission and Indonesia Single Risk Management (ISRM) system. By using this system, hope the time consumed for licensing process can be accelerated, especially for of medical device (Alkes) distribution and Household products (PKRT) marketing authorization licensing.

The statement was delivered by Nila at the opening speech of the Health and Local Medical Devices Technology Development Exhibition, at the Jakarta International Expo, on 9 November, 2017.

Nila also said that the development of this system is aimed to support the acceleration of export and import activities so that it can facilitate the trading while maintaining its safety and quality.

The development of Single Submission and ISRM system is an effort to execute Presidential Mandate No. 91 of 2017 on Accelerating Enforcement of Entrepreneurship (Percepatan Pelaksanaan Berusaha) and currently Ministry of Health is the fifth ministry in Indonesia to implement Single Submission and ISRM system, as Nila said.

Currently, Ministry of Health also encourage the development of local production. As mentioned by Nila Moeloek in the previous speech, pharmaceutical and local medical device production has developed rapidly in the last three years. So it is expected that within the next three to four years, the majority of medical device and pharmaceutical products in Indonesia market will be of local products. At present, the government will focus to prioritize domestic production which related to Presidential Decree No. 44/2016 about Negative Investment List, whereby to establish Class A medical device manufacturer in Indonesia, foreign investment will be limited to 33%. But for Class B, C and D medical device manufacturer is still open 100% for foreign investment. While to establish medical device distributor companies, foreign investment is still limited to 49%.           


  1. Ministry of Health Indonesia accelerate the Marketing Authorization for Medical Devices
  2. Seminar regarding the Registration of Medical Device Class C and D: Discussion about Pharmaceutical and Medical Device Industry Roadmap, 30th March 2017, Park Lane Hotel, RI