Strategic Regulatory Partner for Success in Indonesia

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Indonesia

With steadily growing healthcare market, Indonesia offers excellent business opportunities for foreign medicinal products and medical device manufacturers. Under the authority of Indonesian Ministry of Health (MOH), the Indonesian National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - BPOM) oversees the regulations for medicines and medical devices in the region. To get the market access, manufacturers must navigate through the complex regulatory procedures that range from regulatory requirements, registration procedures and market authorizations.

Freyr, as a global Regulatory partner, can assist manufacturers to navigate through the complex regulatory procedures that range from dossier compilation, regulatory submissions for obtaining market approvals in time. Freyr’s is capable to provide registration and approval assistance for:

Industries We Serve in Indonesia

Indonesia has initiated universal health care for their citizens in 2014. This has greatly influenced the growth of Medical Devices market and led to the rise in the Medical Devices import. The devices in Indonesia are regulated by the National Agency of Drug and Food Control (NADFC) functioning under the Indonesian Ministry of Health (MoH). The latest regulation in place for import of Medical Devices is Decree No. 62 imposed in the year 2017. Foreign companies must appoint an Indonesia Local authorised representative for the process of Medical Device Registration in Indonesia.

Indonesia is one of the leading markets for cosmetic products in the Asian continent. The Indonesian Agency for Drug and Food Control, under the Indonesian Ministry of Health [otherwise called Badan Pengawas Obat dan Makanan (BPOM), is responsible for the cosmetic products registration process in the country. Cosmetic products in Indonesia can be registered only if the applicants are enlisted as legal entities as per Indonesian law mandated by BPOM. Furthermore, obtaining an import license from Indonesia Customs is compulsory for product enrollment. For foreign companies, local agents are required to obtain a license on the companies’ behalf. Companies must ensure that they obtain unique notifications for each product placed in the Indonesian market.

In Indonesia, the National Agency of Drug and Food Control (NADFC), also known as Badan Pengawas Obat dan Makanan (BPOM), Badan POM, or the Indonesian FDA, is a government agency is responsible for the supervision of therapeutic products, narcotics, psychotropic and additive substances, traditional medicines, cosmetics, health supplements, and food safety.

In Indonesia, chemical products like detergents, cleaners (laundry preparations) and disinfectants, and antiseptic preparations products (for example - intended to be used on inanimate surfaces and hard surfaces) fall under the ambit of Regulation of the Minister of Health Number 1190/MENKES/PER/VIII/2010 and classified as Household Health Products (HHP) (Perbekalan Kesehatan Rumah Tangga) abbreviated as PKRT, where they are further classified as per the degree of risk as mentioned below:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Dossier management
  • Regulatory Submissions
  • Good Manufacturing Practice
  • Regulatory roadmap for market access

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with BPOM
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Looking for Regulatory Support in Indonesia

Contact us now for Expert Guidance and Support