As of the deadline for information I understand (January 2022), the MOH may refer to the Ministry of Health or the health authorities of some countries. Parallel imports of medical devices usually refer to medical devices that are legally imported from other countries. To obtain a registration certificate, you will usually need to follow the regulations and procedures of the relevant country or region. Please note that regulations may vary from country to country.
In general, here are the steps you may need to take:
Learn about regulations and policiesBefore you can understand and comply with the medical device registration regulations in your target country or region, you need to have a deep understanding of these regulations and policies. This may include the approval process for documents, requirements for technical documentation, requirements for a quality management system, etc.
Preparation of technical documentation:You may need to prepare a series of technical documents to prove that your medical device meets the standards of the target country or region. This may include product manuals, quality management system documents, production processes, etc.
Choose the right business or agency:In some countries, you may need to register with your local broker or agency. This merchant is usually familiar with local regulations and procedures and will be able to help you navigate the registration process smoothly.
Submit an application for registration:Depending on the regulations of the target country or region, you will need to submit an application for medical device registration to the relevant health authorities. You may have to pay a fee during this process.
Review & Approval:Your application for registration will be reviewed by the health department. The process of an audit may include document review, on-site inspection, etc. Once approved, your medical device will be licensed and can be legally sold and used in the target country or region.
Please note that the above steps may vary depending on the specific country or region. Therefore, it is recommended that you have a detailed understanding of the regulations and requirements of your target market before starting the registration process, and may seek professional legal and medical device registration consulting services. In addition, as information may change from time to time, it is recommended that you review the latest regulations and related information.