Companies with valid license to operate (LTO) as medical device distributor-importer/wholesaler can file for application for product registration. Only complete documents will be accepted during the application.
The application will be reviewed and evaluated if in accordance with the requirements. All complying applications will be issued a certificate of product registration. All non-complying applications will be issued a notice of deficiency. Each company is given a non-extendable ninety (90) days compliance period. All those who will not be able to comply will be disapproved but will be given a period of sixty (60) days to file for re-application and comply with all the deficiencies. In case after this period the application did not satisfactory comply all the requirements, the application will be disapproved and the company needs to file for initial application.
The BHDT is the recommending office for approval of the CPR. All CPRs are forwarded to FDA (BFAD) for approval.
Product registration in the Philippines is the process of obtaining approval from the relevant government agencies to legally market and sell a specific product within the country. It is required for certain products that are subject to regulations, safety standards, or quality control measures imposed by the government. Product registration ensures that products meet the necessary standards and safeguards consumer health and safety.
The government agencies involved in product registration in the Philippines may vary depending on the nature of the product. Some key agencies responsible for product registration include the Food and Drug Administration (FDA) for pharmaceuticals, food, and cosmetics; the Department of Health (DOH) for medical devices and health-related products; the Bureau of Customs (BOC) for imported goods; and the Department of Trade and Industry (DTI) for consumer goods and products.
The specific requirements for product registration vary depending on the product category and the relevant government agency involved. However, common requirements often include:
Product registration in the Philippines offers several benefits, including:
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