Household Health Supplies (PKRT) Distribution Permit Management Services

PKRT Circulation Permit is divided into 2, namely PKL (Import) and PKD (Domestic) Circulation Permit. In contrast to the Edar Permit for Medical Devices, the use of products is intended for use in households and public facilities.

Jasa Pengurusan Izin Edar Perbekalan Kesehatan Rumah Tangga

Table of Contents

What products are included in the PKRT category?

Household Health Supplies, hereinafter abbreviated as PKRT is a device, material, or mixture of materials for the maintenance and care for human health, which is intended for use in households and public facilities. Check if your product falls under the PKRT product category below:

  1. Tissues and Cotton: Beauty Cotton, Facial Wipes, Toilet Wipes, Wet Wipes, Dining Wipes, Cotton Buds, Tissues and other Cotton.
  2. Preparations for washing: Bar soaps, cream soaps, enzyme washes, powder detergents, liquid detergents, softeners, deodorizers and/or fabric softeners, fabric whiteners, hand soaps, other washing preparations.
  3. Cleaners: Kitchenware Cleaners, Glass Cleaners, Floor, Porcelain and/or Ceramic Cleaners, Metal Cleaners, Furniture Cleaners, Carpet Cleaners, Water Purifiers, Drain and Toilet Cleaners, Car Cleaners, Motorcycle Cleaners, Cleaners, and/or Shoe Polishers, Multipurpose/Multipurpose Cleaners, Wood furniture polishers, Woodcraft polishers, Buffing powders and pastes, Other buffing agents, Metal polishers, Other polishers, Hand soaps, Other cleaners.
  4. Deodorizers: Room deodorizer, car deodorizer, water/odor absorber, mothballs, closet deodorizer, phone deodorizer, room deodorizer, other deodorizers.
  5. Baby and Mom Care: Feeding Bottles and/or Pacifiers, Baby Diapers, Breast Milk Storage Containers, Disposable Breast Milk Absorbers.
  6. Antiseptics and Disinfectants: Antiseptics, Disinfectants, Other Antiseptics and Disinfectants.
  7. Household Pesticides: Insect Control in Solid Form, Insect Control in Liquid Form, Insect Control in Aerosol Form, Insect Deterrent, Rat Control, Other household pesticides.

PKRT New Circulation Permit Requirements

A. Administrative Data (Imported PKRT):

  1. Sole Agency Letter (LoA)
  2. Certificate of Free Sale
  3. ISO 9001 Certificate
  4. Letter of Declaration of Quality Safety and Benefit

B. Administrative Data (Domestic PKRT):

  1. Brand Certificate
  2. Letter of Cooperation Agreement Macloon/License Products
  3. Statement Letter of Quality Safety and Benefit

C. Form AA – Formula and Manufacturing Procedure

  1. Formula (qualitative and quantitative) and function of each ingredient used.
  2. Brief and clear manufacturing procedure

D. Form BB – Raw Material and Container Specifications

  1. Raw material specifications and/or requirements
  2. Laboratory test certificates of the raw materials used
  3. Container and lid specifications
    Fluorescence Test Results (Tissue, Cotton, Baby Diaper)
  4. Absorbency Test Results (Baby Diapers)
    Germicidal test results
  5. Phenol coefficient test results (Antiseptic and Disinfectant)
  6. Bisphenol-A free certificate (Plastic Milk Bottles)
  7. Ministry of Agriculture Decree on Pesticide Permanent Permit (Pesticides)
  8. Efficacy Test Results (Pesticides)
  9. Active ingredient test results (Pesticides)
  10. Toxicity Test Results (Aerosol and Lotion Pesticides)

E. Form CC – Finished Product Specification and Stability

  1. Finished product inspection specifications and procedures
  2. Finished product stability and expiration limit (if any)

F. DD Form – Uses and How to Use

  1. Information about the use, how to use, and things that need to be explained including warnings and so on that the user needs to know
  2. Production code and explain its meaning
  3. Marking Design
  4. Supporting Data for Claims other than the main function of the product

Interested in using our PKRT management?

If you have any questions and inquiries regarding the PKRT license process, please feel free to ask us and our staff will be happy to assist and provide solutions to your needs.

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