Application for Visa Registration Certificate for Medical Equipment

According to the Law on Pharmaceutical Management and Law on Amendment of Law on Pharmaceutical Management, Cambodian citizens of either sex or foreigner have the right and may ask permission from the Ministry of Health to open a manufacturing facility and a pharmaceutical export institution in Cambodia.Licensing of the establishment of a manufacturing facility and a pharmaceutical export institution is a requirement before being eligible for pharmaceutical trade, such as import or export, stock, wholesale to legal pharmacies (serum and vaccine) all types for health, including medical equipment and dentists such as equipment, implants, disinfectants and programs that serve in the health sector. Foreign pharmaceutical establishments must also make a pre-registration before being able to obtain import their pharmaceutical products into the Cambodian market.Pharmaceuticals and herbal remedies, including equipment and dentists, are allowed to export and imports must be registered first.Similarly, for the business of exporting and importing cosmetic products, it is necessary to have a license to open cosmetics import and export and register the cosmetic products that will be imported and exported first. This document shows the procedure for requesting a visa certificate, and a list of medical equipment. The medical equipment here is divided into four categories at risk: a. Low, b. Low average, c. High average, and d. High.

The One Window Service “OWSO” is located in the Ministry and has officials from specialized departments such as the Department of Medicine, Food, Medical Equipment and Cosmetics on duty to provide services related to their units. Applicants can also contact the specialized department located in the same Ministry. Department of Medicine, Food, Medical Equipment and Cosmetics The Ministry of Health

• Address: Office of the Ministry of Health, Lot 80, Samdech Pen Nuth Street (289), Sangkat Boeung Kak II, Khan Toul Kork, Phnom Penh
• Email: webmaster@moh.gov.kh
• Website: www.moh.gov.kh

Contact health officials

• Phone: (855-23) 885-970 / 884 909

Applicants can contact the OWSO to request a sample application. In some cases where there is no official at the OWSO, applicants can contact the Department of Drugs, Food, Medical Equipment, and Cosmetics directly to request a sample application or through the website: Department of Drugs and Food (ddfcambodia.com)

Applicants may appoint a representative to apply but must have a power of attorney or letter of introduction.Attachments for Visa Registration List Medical Equipment in classification 1:

• Application (Sample)
• Certificate of Good Practices in Production or International Standard Certificate (Original or certified copy of competent authority)
• Certificate of sale in the country of origin
• Letter of authorization
• 2 sample products or brochures

Attachments for Visa Registration List Medical Equipment in classification 2, 3, 4:

• Application (Sample)
• Certificate of Good Practices in Production or International Standard Certificate (Original or certified copy of competent authority)
• Certificate of sale in the country of origin
• Certificate of registration in other countries (if any)
• Analytical securities issued by manufacturing institutions
• Technical documentation
• 2 sample products or brochures

The implementation of internal procedures is started from the specialized office and goes through a number of hierarchies as defined in the law. Before reaching any decision, the expert official may contact the applicant directly for any necessary supplement required for the adequacy of the request, such as requiring the applicant to submit additional documents to the expert officer.

Following the issuance of the permit decision on the application, the professional officer will contact the applicant to pay the service fee 400,000-riel for visa registration, list of valid medical equipment for three years and for renewal request, Ministry pricing, 70% of the original service price.

There are a number of cases where the applicant is told to obtain a license from the department itself. Applicants should come with an ID or other credentials along with a receipt of a word/receipt.