FDA Certificate of Product Registration (CPR) Housing Service

The process of obtaining a Certificate of Product Registration (CPR) for medical devices, food, supplements, pharmaceuticals, and other regulated products in the Philippines can be a lengthy and complex one. However, there is a solution that can expedite this process and help businesses navigate the regulatory landscape more efficiently. This solution is known as “CPR Housing,” and it is offered by companies like Triple i Consulting, which serves as a 3rd party host for the CPR.

Understanding CPR and its Importance:

In the Philippines, the Certificate of Product Registration (CPR) is a critical requirement for companies that wish to import, distribute, or sell regulated products. It is issued by the Food and Drug Administration (FDA) and serves as evidence that a product has undergone evaluation and is compliant with the country’s regulations. Without a valid CPR, businesses cannot legally market their products in the Philippines.

The CPR Housing Concept:

CPR Housing involves a two-step process. The first step is for the company seeking a CPR to register a business entity in the Philippines. This involves first incorporating a company in the Philippines. After the company has been registered, it must obtain a License to Operate (LTO) from the FDA.

The LTO is a permit granted to businesses that comply with the FDA’s quality management system requirements and other relevant regulations. Once the LTO is obtained, the company can then proceed with the CPR application.

Triple i Consulting as an Authorized Agent:

Triple i Consulting offers CPR Housing services, acting as the client’s authorized agent during the CPR application process. This means that while the company registration is underway and before the LTO is obtained, Triple i Consulting can initiate the FDA registration process for its client’s product(s). This parallel approach significantly reduces the time it takes to get products to market, as the CPR can be transferred to the new entity once it is ready.

To apply for a CPR, companies must submit a comprehensive set of documents, including but not limited to:

1. Product Information
2. Technical Documentation
3. Quality Management System (QMS) Documentation
4. Clinical Data (if applicable)
5. Labeling and Packaging Information
6. Manufacturing and Importation Details
7. Post-Marketing Surveillance Plan
8. Product Samples (if required)

Legalities and ASEAN Medical Device Directive (AMDD):

The CPR application process must adhere to the ASEAN Medical Device Directive (AMDD), which harmonizes medical device regulations among member countries. Compliance with AMDD standards ensures that products meet international quality and safety standards.

Medical devices are categorized into four classes in the Philippines based on the level of risk associated with their use. The classification determines the scrutiny level and the CPR application requirements.

1. Class A: Low-risk devices
2. Class B: Low to moderate-risk devices
3. Class C: Moderate to high-risk devices
4. Class D: High-risk devices

A CPR is not limited to medical devices; it is also required for various other regulated products, including:

1. Medical Devices
2. Pharmaceuticals
3. Food and Food Supplements
4. Cosmetics
5. Household Hazardous Substances
6. Pesticides and Fertilizers

The application process for a CPR involves a thorough review of the submitted documents and, if necessary, a site inspection. The timeline for approval can vary depending on the complexity of the product and the completeness of the application.

Regarding costs, CPR application fees can differ based on the type of product and its classification.

Obtaining a Certificate of Product Registration (CPR) is a crucial step for businesses looking to enter the Philippine market with regulated products. CPR Housing, as offered by Triple i Consulting, provides a strategic advantage by allowing the FDA registration process to begin concurrently with the company formation. This streamlined approach helps businesses bring their products to market faster than the traditional registration process, enabling them to seize opportunities and thrive in the dynamic Philippine market. By leveraging CPR Housing services, companies can navigate the regulatory landscape with ease and confidence, making their mark in the Philippines with imported products efficiently and legally.

Selling an item in the Philippines entails a tedious and time-consuming registration process, making it advisable to seek professional assistance. Triple i Consulting, an ISO-Certified company, is dedicated to expediting the certification and approval of clients’ products by the Philippine Food and Drug Administration (FDA).

To ease this process, we offer our expertise in obtaining FDA approvals promptly. Should you require our assistance, you can reach us through various channels:

• Contact Us Here
• Fill out the form below
• Call us at +63 (02) 8540-9623
• Email us at info@tripleiconsulting.com

Feel free to book an initial consultation with one of our FDA experts to kickstart the registration process for your product.