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Only locally registered companies in Malaysia, recognized by the Companies Commission (SSM), are permitted to apply for an establishment license, proceed with medical device registration, and obtain export permits. Once registered with the SSM, companies can access MeDCASt2.0+ to initiate their application for an Establishment License, tailored to their specific activity: Manufacturer’s License, Importer’s License, Distributor’s License, or an Authorized Representative’s License. Having an Establishment License is a prerequisite for registering a medical device in Malaysia.
Since only local companies can apply for an Establishment License, foreign manufacturers have several options to register their medical devices in Malaysia:
Medcast, also known as the Medical Device Centralised Online Application System (MeDCASt), is an online platform managed by the Malaysian Medical Device Authority (MDA). It is the primary system for handling various applications related to Establishment Licensing, Medical Device Registration, and Export Permit.
Parties involved in the medical device industry in Malaysia, including manufacturers, importers, exporters, distributors, and Authorized Representatives, are required to utilize Medcast for submitting applications, especially for medical device registration with the MDA.
Originally launched in July 2013, Medcast underwent an upgrade to Medcast 2.0 in January 2019. As of February 1, 2022, MDA has introduced further enhancements with Medcast 2.0+ to improve the user experience and service quality.
Medcast 2.0+ introduces new features such as the Change Notification Module, Device Study sub-module (under the Clinical Research module), Clinical Research Use sub-module (under the Clinical Research module), and Demonstration for Marketing Notification and Payment module. These additions reflect MDA’s commitment to continuous improvement in service delivery for stakeholders in the medical device industry.
| Registration Stage | Timeline | Fees (MYR) |
|---|---|---|
| Submission of Application | 2-4 weeks | 500-2000 |
| Document Preparation | 2-3 weeks | 1000-3000 |
| Compliance Assessment | 4-6 weeks | 2000-5000 |
| Inspection (if required) | 6-8 weeks | 3000-7000 |
| Review and Approval | 8-12 weeks | 5000-10000 |
| Certificate Issuance | 2-4 weeks | 1000-2000 |
| Renewal | Every 1-3 years | 2000-5000 |
| Post-Market Surveillance | Ongoing | N/A |
*NOTE – Please note that the timelines and fees provided above are approximate and may vary depending on factors such as the complexity of the medical device and the responsiveness of the regulatory authority.
| Class | Registration Pathway |
|---|---|
| A (Low-Risk) | MDA Application |
| B (Low-Moderate) | CAB Assessment followed by MDA Application |
| C (Moderate-High) | CAB Assessment followed by MDA Application |
| D (High-Risk) | CAB Assessment followed by MDA Application |
*Note – Conformity Assessment Body
In Malaysia, the term ‘medical device’ encompasses a wide range of products utilized in healthcare for diagnosis, prevention, monitoring, or treatment purposes, excluding drugs. This definition also includes in-vitro diagnostics (IVDs). To comply with regulatory standards outlined in Section 2 of Act 737 (refer to guidance document MDA/GD/0006), any medical device must undergo registration before importation, exportation, or placement in the market.
To register a medical device in Malaysia, several documents are required, all of which must be submitted in English. Primarily, a Common Submission Dossier Template (CSDT) must be completed. This comprehensive dossier encompasses an :
Additionally, existing regulatory approvals or market authorizations must be included.
Certain products may necessitate supplementary documentation, particularly those involving radiation, derived from animal tissues, or featuring Bluetooth and wireless network functionalities.
When it comes to medical devices registration in Malaysia, a Certificate of Conformity from an authorized local conformity assessment body (CAB) is essential. Under the fast track system, devices that already have approval from reference countries can receive provisional registration. This allows up to 5 years to submit the locally issued Certificate of Conformity.
In Malaysia, the process of medical devices registration is overseen by regulatory authorities to ensure compliance with established standards and regulations. Here are the key entities involved in the medical devices registration process:
By collaborating with these regulatory authorities, manufacturers can navigate the medical device registration process in Malaysia effectively and ensure compliance with regulatory requirements, thereby gaining access to the Malaysian market for their medical devices.
December 3rd, 2024
December 3rd, 2024
