FDA Registration Requirements for International Brands 2024

What is FDA Registration?

FDA registration involves submitting detailed information about your products, manufacturing facilities and processes, quality control, labeling, recall procedures, and more. FDA compliance can seem time consuming and complex, but it doesn’t have to be. More than 30,000 food and beverage, dietary supplement, drug, medical device, and cosmetics companies trust AsiaCommerce to help them comply with FDA registration regulations with ease.

If you produce products in the categories below, FDA registration may be mandatory:

• Food, beverages, or dietary supplements
• Cosmetic products
• Animal and veterinary products
• Medical devices
• Drug products (including OTC)
• Tobacco products
• Radiation-emitting devices (RED)
• Biologics

Each product category has specific exemptions and AsiaCommerce can help you determine whether you must register your facility. By registering your facility with FDA, you help promote consumer safety and keep your company FDA compliant.

Requirements for FDA

If you are planning on expanding your company into Asia or specifically Southeast Asia within a regulated industry, then you will need to ensure compliance through proper FDA registration and certification. Here are some FDA certification you need to apply from Southeast Asia country.

Philippines

The Food and Drug Administration reports to the Department of Health in the Philippines and monitors regulations for any business activities that involve manufacturing, trading, and distributing (wholesale, import, or export) within FDA-regulated industries:

• Food and beverage
• Cosmetics
• Drugs and pharmaceuticals
• Medical Devices and In-Vitro diagnostic devices / Reagents
• Household/Urban Hazardous Substances (HUHS) and pesticides
• Toys and childcare articles

Before your company can register any products, however, you must obtain a License to Operate (LTO) from the FDA. The LTO in the Philippines enables your company to legally carry out any of the aforementioned operations within FDA-regulated industries. To learn more, check out our related article on how to secure a License to Operate in the Philippines.

Types of FDA certificates in the Philippines

This certificate is essential for company operations as it ensures that any goods being produced or sold meet necessary standards. The designation of the certificate varies depending on the type of product being assessed: 

• Certificate of Product Registration (CPR): The most common type of certificate, applies to food, drug and HUHS products
• Certificate of Product Nomination (CPN): Applies to cosmetic products
• Certificate of Medical Device Registration (CMDR): Applies to medical devices and related products
• Each certificate processing comes with specific fees which are determined on a case-by-case basis. 

How to apply for the FDA Certificate of Product Registration in the Philippines

Once you have obtained a License to Operate in the Philippines for your company, you can apply for the FDA certificate for your regulated products. Certificates are valid for 1 to 2 years and are subject to renewal upon expiration. To apply for an FDA certificate of Product Registration, you will need to submit the following:

1. Application form: must be accompanied by a valid LTO issued by the FDA in the Philippines
2. Product labels: Copies of product labels in all packaging sizes, including product photos in all packaging sizes and from different angles.
3. Supporting documentation must be provided for logos, seals, and certification per labeling regulations (e.g. Halal, Sangkap Pinoy Certificate, product information)
4. Product documents: Must support any product claims, such as documents detailing physiochemical and microbiological regulations.
5. The specification must fall under the ASEAN directive regulations.
6. Certificate of analysis: Details on the product, must be relevant to food standards and regulations compliance.
7. Product Sample: It is mandatory to provide a physical representative sample of the product, which must appear as it would commercially and complete with all labels.

It is important to note that an FDA certificate is rendered invalid if any changes are made to the product. If changes are brought to the product, you will need to apply for a renewal. Emerhub’s team of advisors is well-versed with FDA registration in the Philippines and can help you prepare the necessary documents and handle the application and renewal process for you. 

Malaysia

The products that are registered in Malaysia are approved by the Drug Control Authority (DCA) for the purpose to be sold or used in Malaysia. These products have been evaluated and tested in terms of the quality and safety of the product.

Each registered product has a registration number which is printed on the product label and/or on the product packaging1. The product registration number will start with ‘MAL’ followed by an 8 digit numbers and lastly the category of the product. Example: MAL19976399X, MAL15065021NCR, MAL14035062TS and others.

(A: prescription product, X: non-prescription product, N: health supplement, T: traditional, H: veterinary)

(C: contract manufacturer, R: repacker, S: second source, E: product for export only, Z: zero-rated GST)

Types of drug product required to be registered in Malaysia

Examples of the types of drug products required to be registered with DCA are:

a. Pharmaceutical products containing scheduled poison

b. Pharmaceutical products containing non-scheduled poison

Including:

• Plaster containing medicine
• Antiseptic / Disinfectant for the use on human skin
• Diagnostic agent for the use in human (in vivo)
• Health supplement for example; Probiotic, Chitosan

c. Natural products (Herbal / Traditional)

Including:

• Homeophathic medicine
• Ayurvedic medicine
• Medicated plaster
• Herbal Tea
• Health supplement for example; Spirulina, Chlorella, Royal Jelly, Bee Pollen and others.

d. Veterinary Products

Including:

• Granule
• Paste
• Water soluble powder
• Injectable
• Powder for injection
• Oral powders
• Capsule / Tablet
• Topical ophtalmic and otic products

Scheduled poison : Please refer to the Schedule Poison List, which is available online via https://pharmacy.moh.gov.my/ms.

Regulatory body responsible to register drug products

The National Pharmaceutical Regulatory Agency (NPRA) is a regulatory body which is responsible to register drug products in Malaysia.

Criteria for registration of drug products

Products to be registered in Malaysia must fulfil the registration requirements determined by the Drug Control Authority (DCA), especially from the aspect of safety, quality and efficacy of the product.

Other criteria that will be taken into consideration are:

• The need for the products, the potential of abuse, the amount of registered products, dosage form and others.
• Therapeutic effect.

Drug registration process in Malaysia and registration requirements in general

The applicant for product registration is known as the Product Registration Holder (PRH) and must be from a registered company in Malaysia with the scope of business in area of health / pharmaceutical products.

If the PRH is not the product owner, the PRH will be required to obtain an Authorisation Letter from the product owner so that the PRH will be accountable for all activities involving the quality, safety and efficacy of the product. This includes activities such as updating the product information / any application sent to the NPRA.

The registration of product is via online through the QUEST system which can be assessed on the NPRA website http://npra.moh.gov.my.

In general, an applicant has to register membership as a user of the QUEST system and purchase a USB Token which contains the user’s Digital Certificate before he/she can access to the system for submitting product registration. The user’s Digital Certificate is a software which can be installed into the computer of the user. This USB token can be purchased from MSC Trustgate.

Indonesia

With a population exceeding 270 million, witnessed a significant economic milestone when it transitioned to an ‘upper-middle-income country’ status in July 2020, as declared by the World Bank. This transformation is attributed mainly to Indonesia’s growing middle class.

The new status is resulting in increased consumption rates and diverse market demands. The Indonesian government’s efforts to simplify regulations for foreign investments and the rapid adoption of digital technologies further. They plan to contribute to the nation’s attractiveness to foreign companies and investors.



Understanding BPOM Indonesia and Its Regulatory Role

In essence, Badan Pengawas Obat dan Makanan (BPOM) is Indonesia’s equivalent of the Food and Drug Administration (FDA). BPOM regulates and oversees national policies, standards, and regulations governing various products, including food, beverages, medicines, medical devices, health supplements, and cosmetics imported, distributed, and sold in Indonesia.

In summary, here are the key functions of BPOM:

• Formulating new policies, standards, procedures, and criteria.
• Updating existing policies, standards, procedures, and measures.
• Implementing and supervising enforcing policies, standards, practices, and actions.
• Conducting laboratory testing of products.
• Inspecting manufacturing, distribution facilities, and product sampling.
• Issuing certificates and permits.



Quality Standards for Indonesia Products

Indonesia’s pursuit of economic growth prioritizes foreign direct investment and international collaboration to establish

global standards for product registration in Jakarta and Indonesia. Essential quality standards include:

• ASEAN Consultative Committee for Standards and Quality (ACCSQ)
• Pacific Area Standard Congress (PASC)
• Asia Pacific Laboratory Accreditation Cooperation (APLAC)
• Codex Alimentarius Commission (CAC)
• International Laboratory Accreditation Cooperation (ILAC)



How to Register Your Product through BPOM?

To bring medicines, traditional cures, cosmetics, food supplements, and processed foods into Indonesia, comply with the safety standards set by the Indonesian National Agency of Drug and Food Control (BPOM). The process, governed by Regulation No. 12 of 2015, mandates registration before customs clearance.

Follow these steps to obtain a Letter of Import (SKI) from the Head of BPOM:

Register online at BPOM’s or INSW’s website using Single SignOn.

Upload required documents:

• Application letter
• Letter of responsibility
• Importer Identification Number (API) – NIB
• Trading Business License (SIUP)
• Tax ID (NPWP)
• Power of attorney letter for importing
• List of HS code for the product
• For drug SKI, include the Pharmaceutical Industry License.



Complete e-payment as Non-Tax Revenue (PNBP)

Submit electronic documents:

• Distribution approval license
• Certificate of analysis
• Invoice
• Proof of Payment of Non-Tax Revenue (PNBP).
• For vaccine and serum applications, include: Batch/lot release certificate and summary of batch/lot protocol
• Certificate of analysis
• Letter from the producer.
• For processed food, a letter of recommendation may be required. Additional documents may be requested based on the product category.

Easy Way to Expand Your Brand to ASEAN

Navigating product registration in ASEAN can be challenging and risky when done independently. AsiaCommerce is ready to help you to take this intricate process, ensuring you meet country regulations. We will help you with handling the complicated rules for imported products, establishing the proper structure for product imports, ensure your paperwork is complete and accurate, speeding up approvals.
If you’re interested in exploring market opportunities in Indonesia, visit our service page for more information. Our team will work with you every step of the way, from finding a supplier, shipping door-to-door, and handling import documents to ensure your market entry to Indonesia.