Entering the Indonesian medical device market requires strict adherence to local regulatory procedures. The Indonesian Ministry of Health is responsible for medical device registration, ensuring all products meet requirements before being marketed...
BPOM requires that importers use warehouses or storage facilities that meet Good Distribution Practices (GDP) standards. Key requirements include: equipping appropriate temperature and humidity control equipment according to product type; establishing a comprehensive pest control system; and separating raw material areas, finished product areas, and...
Laboratory testing is a core requirement for BPOM ML registration of processed foods, and the scope of testing depends on the product category. There are two main areas of focus: 1. Chemical contaminant testing. According to BPOM Regulation No. 16 of 2019, imported processed foods...
One of the most frequently overlooked aspects of BPOM ML registration is label compliance. Indonesian food labeling standards are detailed and stringent; a product that passes safety testing may still be rejected during the registration process due to label non-compliance. According to 1999...
To ensure the smooth registration of non-pharmaceutical products with the Indonesian Food and Drug Administration (BPOM), regulate product labeling claims, guarantee that claims comply with BPOM regulatory requirements, and mitigate registration and market circulation risks, this document is specially formulated...
Terminology Definitions This regulation defines the following terms: 1. Natural pharmaceutical ingredients: refers to single ingredients, mixtures, or finished products derived from plants, animals, microorganisms, minerals, and other natural resources, including compositions of the aforementioned natural ingredients; this category...
The problem is that our company plans to procure an antidote to treat a type of poisoning (a hazardous substance produced during mining) that cannot be sold in Indonesia. This medicine can only be purchased from abroad, but it does not have a distribution license in Indonesia. A...
To ensure public medication safety and prevent drugs that do not meet Indonesian safety and quality standards from entering the market, the Indonesian government has established a drug registration and approval evaluation system. Drugs must complete approval before they can be distributed and circulated within the country. This regulatory system is overseen by the Indonesian Food and Drug Administration...
Good Cosmetic Manufacturing Practices (CPKB) cover all stages of the cosmetic manufacturing process, with the core objective of ensuring that manufactured cosmetics consistently meet the quality requirements for their intended use. The cosmetics industry is required to strictly implement CPK in all production activities...
According to Annex II.3, Part II.E of Regulation No. 39 of 2013 issued by the Director General of the Indonesian Food and Drug Regulatory Agency (BPOM), concerning the public service standards of food and drug regulatory agencies, and amended by Regulation No. 15 of 2016 issued by the Director General,...
A. Determination of Microbial Contamination in Cosmetics A.1 Determination Principle of Mold and Yeast Count and Total Colony Count Tests in Cosmetics: This method involves counting molds and yeasts on selective agar medium. If the sample is estimated to be contaminated...
