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Malaysia Medical Device Registration
Medical device product registration in Malaysia is overseen by the Medical Device Authority (MDA) of the Ministry of Health Malaysia (MoHM), as stipulated under the Medical Device Act 2012, which was made effective on July 1, 2013. According to the act, medical devices require registration with the MDA before being imported and placed on the market.
Medical Device Status
In Malaysia, a medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease or injury.
The registration process and guidelines closely follow ASEAN Medical Devices Directive (AMDD) standards. Devices are classified into four classes A, B, C and D, ranked from low to high risk categorization. Additionally, there is a fifth category for combination devices. The registration routes vary based on the classification of the device:
|CAB Fees||MOH Fees||Review Times|
|Class A||n/a||MR100||6 to 8 weeks|
|Class B||MR1,300||MR1,250||3 to 6 months|
|Class C||MR1,300||MR2,500||3 to 6 months|
|Class D||MR1,300||MR3,750||3 to 6 months|
|Combination Device||MR1,300||MR5,750||3 to 6 months|
Device Conformity Assessment
Applications follow a two-step process whereby the initial completeness review is conducted by an authorized, private Conformity Assessment Body (CAB). The CAB will issue a Certificate of Conformity once approved. With this, the dossier is submitted to the MDA for evaluation. CAB evaluation and consulting fees will vary depending on a device’s risk classification. Device conformity includes both administrative and technical documentation, such as Instructions for Use, product descriptions and proper labeling in accordance with Common Submission Dossier Template (CSDT) application requirements.
In July 2020, Malaysia released the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system. The regulation states the Malaysia Authorized Holder (MAH) listed on a product’s registration certificate is responsible for all post-market vigilance communications with the Ministry of Health.
Quality Systems Conformity Assessment
Quality systems conformity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.
Medical device product registration in Malaysia is fairly efficient.
Exceptions to Home Country Approval Requirement
Recent guidance has provided for registration exemption for Class A devices (non measuring, non sterile) and a fast track provisional registration process for all other devices that have reference country approval. The fast-track route effectively extends the grace period for full registration for another 5 years.
Australia – Canada – European Union – Japan – United States
Validity and Renewal
The application requires a Certificate of Conformity from a local, authorized conformity assessment body (CAB). Under the fast track system, devices with reference country approval have up to 5 years to submit the locally issued Certificate of Conformity and will be issued provisional registration in the meantime.
License Holder Requirements
Medical Device registration applications must be submitted via the on-line MEDCAST system by a licensed, local entity that also acts as license holder, or Malaysia Authorized Holder (MAH).
Licenses can be transferred from one Authorized Representative (AR) to another. The new AR will fill out an application on the MoH MEDCAST online portal. Required documents include the Current AR Declaration Form (Annex B – MDA/GD0041), Termination Letter, and Letter of Authorization from the new AR. The MoH charges about RM 500 (USD$ 115) per medical device registration ID.
Benefits of Independent License Holding through Asia Actual
- Sell directly to multiple regional distributors, avoiding mark-up by a national importer
- Increase transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
- Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual for assistance to confirm the cost and time lines that apply to your medical devices. Asia Actual also has experienced, top level consultants in Malaysia to manage the application process.
Malaysia Regulatory Support
Kenna’s Regulatory Hint
“Though Halal certification is not required for registration in Malaysia, companies may seek certification in order to expand their potential end customer base.”
US: +1 512 898-9222
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