FDA Registration Cambodia | ISO Certification

FDA

Registration

The U.S. FDA (United States Food & Drug Administration) requires facilities that manufacture, process, pack or store foods, drugs, and medical devices marketed in the U.S. to file registrations with the FDA.

FDA Registration

How to Register with the FDA

K2A Management is an FDA consultant in Cambodia. We help Cambodian clients register their products with the FDA and helps companies comply with U.S. Food and Drug Administration (FDA) regulations quickly and properly.

Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.

Cosmetics

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

Drugs

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

Food

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Medical Devices

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

FDA Guidance Documents

Guidance documents describe FDA’s interpretation of FDA policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. FDA guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies.

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FDA Registration in Cambodia

K2A Management Cambodia helps companies comply with U.S. Food and Drug Administration (FDA) regulations quickly and properly and provide US FDA Agent Service in Cambodia and provide the FDA Registration Certificate.

If you wish to register your manufacturing facility with FDA you must have appointed a US FDA Agent on your behalf. We at K2A Management Cambodia provide our service to act our partners in US to act as your official Agent on your behalf.

The responsibilities of the US as FDA Agent are limited and include:

Assisting FDA in communications with the foreign establishment.
Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States.
Assisting FDA in scheduling inspections of the foreign establishment.
If FDA is unable to contact the foreign establishment directly or expeditiously,
FDA may provide information or documents to the US FDA Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Medical Device Registration-Cambodia

Medical Device Registration Regulation in Cambodia
Medical Device Registration Under FDA

Medical devices are regulated by the Department of Drugs and Food (DDF) in the Ministry of Health in Cambodia whose objective is to ensure the quality and safety of medical devices that are locally produced or imported from other countries. They follow regulations that are in line with the ASEAN Medical Device Directive (AMDD).

Most establishments that are required to register with FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo).

How to Register and List

FDA Registration Process

The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver.

The registration of a medical device establishment is a two-step process. First you must pay the annual registration user fee. Once you have paid the fee, you can then complete the registration process. Your registration is not considered complete until you have

paid your annual registration user fee,
submitted your registration and listing information electronically, and
received e-mail notification from FDA that all requirements have been met.

Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM).

Each owner/operator must have an account ID and password to use FURLS. If the owner/operator has designated another person to be the official correspondent, the owner/operator must create a subaccount with a separate account ID and password for the official correspondent.

Firms that are already registered must always use their assigned account ID and password. Never create a new FURLS account if you already have one. Creating a new account will prevent you from accessing your current registration information and delay the completion of your correct registration.

FDA US Agent (FDA Agent)

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (FDA US Agent or FDA Agent) for that establishment.

Information about a foreign establishment’s US FDA Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one US FDA Agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the US FDA Agent.

The US FDA Agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the FDA US Agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the US FDA Agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new FDA US Agent to satisfy the regulatory obligation.

K2A Management in Cambodia provides FDA consultancy services for manufacturers in Cambodian to register their facility and products with a smooth transaction and expert advisory services.