01
Company Legality Documents (NIB, Deed of Establishment, and Others)
Valid proof that the business entity has been officially registered and operates in accordance with applicable legal provisions.
Medical Device Distribution License Service
The Medical Device Distribution License is an official license issued by government agencies such as BPOM or the Ministry of Health, stating that a product meets safety, quality, and efficacy standards, and is legal to be distributed in the Indonesian market. IZIN.co.id is ready to provide official processing assistance for the smooth running of your business.
Medical Device Distribution License Processing Packages
Pilih layanan pengurusan Izin Edar Alat Kesehatan yang sesuai dengan kebutuhan Anda.
Dapatkan Promo & Penawaran Menarik
Jika Anda ingin menyampaikan pertanyaan tentang perizinan, legalitas maupun pendirian perusahaan jangan ragu untuk menghubungi kami. Kami akan sangat senang melayani permintaan Anda sesegera mungkin.
Requirements
Medical Device Distribution License Processing Requirements
To obtain a Medical Device Distribution License so the product can be officially marketed, companies need to prepare the following documents:
02
Product Specifications and Composition
Complete details about raw materials, additives, product formulas, and physical or chemical characteristics of the product.
03
Label and Packaging Design
Product labels and packaging must contain information that complies with regulations, such as product name, composition, usage instructions, batch number, and expiration date.
04
Production Process and Quality Control
Explanation of the production flow from raw materials to finished products, as well as quality control procedures to ensure product safety and quality.
05
Accredited Laboratory Test Results
Proof of testing results from an accredited laboratory to ensure that the product meets required safety, quality, and efficacy standards.
06
GMP, CPOTB, or CPPKRTB Certificate (If Required)
Good Manufacturing Practice certificate, depending on the product type, as proof that the production process is carried out according to standards set by authorities.
Products Requiring a Medical Device Distribution License
Processed food and beverages
Traditional medicine and health supplements
Cosmetics and skincare
Household health products (PKRT)
Medical devices
Medicines and pharmaceuticals
Veterinary and animal products
Infant and child nutrition products
Why is a Medical Device Distribution License Important?
Here are some reasons why a Distribution License is crucial to your business:
Legal Requirement for Product Distribution
Without a Distribution License, products cannot be legally sold in physical stores or online.
Enhances Consumer & Distributor Trust
Officially registered products are more trusted and easily accepted by the market.
Supports Business Expansion
Required for entering modern retail, participating in tenders, or exporting.
Complies with Government Regulations
Avoid sanctions, product recalls, or business closure.
Trusted by various partners & clients
Partners and companies that entrust their company establishment, licensing, and business legality to IZIN.co.id.
Supported By
β’Featured On
β’Our Clients
Our Clients
Featured On
Supported By
CUSTOMER REVIEWS
4.8/ 5.0
212 Google reviews
β IZIN.co.id as a licensing consultant partner for your business needs π We wish you success and progress in managing and developing your business. β
Desti m Nur
β Thank you for trusting and using IZIN.co.id as a licensing consultant partner for your business needs π Good service and responsive βοΈβοΈβοΈβοΈ β
Adityo Dharma
β Great, this is the first time a legality service provider has the ri Google Play application. PERMISSION-GO quality is different from the others. β
Resty
β The most recommended PT Development Services in Jakarta, has Virtual Office facilities to support the increasingly widespread digital world as well. β
Melinda Thea
β The process for managing PT Individual aq is fast. Fast response. I will refer it to friends who want to take care of the legality of the company. π β
Putri Putri
β First off all we think that we have to communicate with many related functions, but with Izin Co Id then we just directly stright in one line and completed. Well Done β
Moch Rizal
β Great professional service from IZIN.co.id, they are responsible and accountable, they did what they spoke (integrity), very kind and polite. In short, they are PROfessional. β
Julia Anita
β I highly recommend it to everyone so that the business runs smoother and you don't worry, immediately dealing with company legality at IZIN.co.id. β
David Suprayogi
