Classification of Products:
Determine the classification of your medical product as per the local regulatory framework. Different classes of products may have different licensing requirements.
Application Submission:
Submit a licensing application to the Pharmacy and Poisons Board of Hong Kong. This application typically includes detailed information about the product, its formulation, manufacturing processes, quality control measures, and clinical data (if applicable).
Evaluation and Assessment:
The DoH will evaluate the submitted information to ensure that the medical product meets the required safety, efficacy, and quality standards. This may involve a thorough review of the product's documentation and may also include inspections of manufacturing facilities.
Issuance of License:
If the product meets all the necessary criteria, the Department of Health will issue a license for the marketing and sale of the medical product in Hong Kong. The license may have specific conditions and requirements that the licensee must adhere to.
Post-Market Surveillance:
After the product is licensed, post-market surveillance activities are conducted to monitor the safety and performance of the medical product in the market. Manufacturers or license holders are required to report adverse events or product defects promptly.
