Requirements and Process for Medical Device Registration in Malaysia
The registration of medical devices in Malaysia is a crucial process to ensure the safety and compliance of these devices with the standards set by the national health authorities. In this article, we will examine the requirements and process for medical device registration in Malaysia in detail.
Documentation Preparation:
The first step in the registration process is the preparation of required documentation such as technical information, quality certificates, and test reports. These documents need to be prepared carefully and in accordance with the format specified by the health authorities.
The documentation, normally named Technical Files @ Technical Dossier is a set of technical documentation that indentify and provide the compliance evidence and proof of product meeting safety and performance of devices.
It also act as the main reference to the device safety and compliance for Pre-Market Approval eg MDA Malaysia.
Here is the example of Technical Files content:
1. Common Submission Dossier Template
2. Essential Principle of Safety and Performance @ GSPR (General Safety and Performance Requirements)
3. Declaration of Conformity
4. Authorised Letter from Manufacturer
5. Intended Use and Product info/drawing
6. Instruction for Use or/ and product labeling
7. Risk management report
8. Manufacturer information including ISO 13485 Cert/CE Cert/ Manufacturing Site detail
9. Pre Clinical Test including Physical, Chemical and other performance test eg: Biocompatibility
10. Clinical Evaluation Report
11. Validation and Verification report
12. Medical Device List - Product Classification and Variant List
13. Harmonised Standard List
14. Labelling including carton, inner box and product label.
(kindly contact Ummah Synergy Ventures for sample and consultation of named product above)
Registration Application:
Once the documents are prepared, the applicant needs to submit a registration application to the national health authorities. This application should include details such as applicant information, device information, and supporting documents.
Assessment and Testing:
The health authorities will assess the submitted documents and conduct necessary tests on the devices. These tests aim to ensure the safety, effectiveness, and quality of the medical devices.
Approval and Registration Certificate:
If the medical devices successfully pass all tests and assessments, the health authorities will grant approval and issue a registration certificate. This certificate signifies that the devices have been deemed safe for use in Malaysia.
Market Monitoring:
After registration, the health authorities will continue to monitor the devices in the market to ensure ongoing compliance with health standards. This includes regular inspections and prompt actions in case of any safety issues.
Importance of Medical Device Registration:
The registration of medical devices in Malaysia plays a crucial role in ensuring the safety, quality, and effectiveness of these devices. It protects users from unforeseen risks and provides confidence to users about the effectiveness of the devices. Additionally, registration enables health authorities to control and monitor the circulation of medical devices in the market to ensure safety and quality of products used by users.
