The registration process for surgical control system medical devices in Malaysia involves multiple steps as follows:
1.Preparation of registration documents:
Product description: including details such as product name, specification, model, use, etc.
Manufacturer information: including manufacturer name, address, contact information, etc.
Technical documents: including product specifications, design descriptions, performance evaluation, quality control and other technical documents. For surgical control system medical devices, these documents need to describe in particular detail the product's functionality, operating principle, safety, and compatibility with other medical devices.
Verification and validation reports: Depending on the requirements of the product classification, verification and validation reports may be required to demonstrate the safety and effectiveness of the product.
Relevant licenses and certificates: including production licenses, quality management system certifications, etc. For surgical control system medical devices, ISO 13485 quality management system certification may also be required.
Labels and instructions: Provide product labels and instructions for use so that users can use the product correctly and safely.
2.Submission of registration application: Submit the prepared registration documents to the Malaysian Medical Devices Authority (MDA). The application process typically includes registration and submission of electronic documents. Before submission, it is advisable to double-check the documents for accuracy and completeness of the contents.
3.Audit and Assessment: MDA will review and evaluate the submitted registration documents to confirm that the product meets the regulatory requirements in Malaysia. This may take a while, depending on the complexity of the product and the workload of the MDA.
4.Certificate of Registration Issuance: If the registration application is approved, the MDA will issue a Medical Device Registration Certificate. This will allow surgical control system medical devices to be sold and used in the Malaysian market.
In addition, for overseas manufacturers, there are also the following points to pay attention to:
Authorized Representative: Before entering the Malaysian market, a local authorized representative needs to be appointed to carry out matters such as registration application and post-market follow-up of medical device applications. The authorised representative must be a Malaysian citizen or permanent resident and hold a business license and Good Distribution Practice for Medical Devices (GDPR) certificate.
Registration Category: Understand and determine the registration category of the surgical control system medical device. This will help to prepare the correct registration documents and choose the right registration path.
Clinical evaluation report: If the surgical control system medical device needs to be clinically tested, the relevant clinical evaluation report needs to be provided. These reports should detail the safety, effectiveness, and performance of the product.
Overall, the registration process for surgical control system medical devices in Malaysia requires careful preparation and compliance with the relevant regulatory requirements. By working closely with MDA and providing complete registration documents, it is possible to successfully obtain the registration certificate and sell the products in the Malaysian market.