How do I register my medical device in Malaysia?

How do I register my medical device in Malaysia?

Use ASEAN Common Submission Dossier Template (CSDT) format technical file. Request a technical review of your documentation by a licensed Conformity Assessment Body (CAB). After satisfactory audit by CAB, the verification Certificate is issued. Submit application with CAB certificate and audit report to MDA.

How can I sell my medical device in Malaysia?

To apply for Establishment License as Importer and/or Distributor with MDA, three steps to go as well: Obtain Letter of Authorization (LoA) from the Authorized Representative. Certified with Good Distribution Practice for Medical Device (GDPMD) by the Conformity Assessment Body (CAB) recognized by MDA.

What is MDA license?

Establishment Licence Application Status – Medical Device Authority (MDA)

How do I import my medical device to Malaysia?

Importation of Medical Devices into Malaysia Once obtaining the relevant Certificate of Registration from Medical Device Authority (MDA) Malaysia, all medical devices (goods) to be imported, whether or not subjected to import duties, must be declared in writing on Customs Import Form No. 1 (Borang K1).

How do I get a Gdpmd license?

How to apply the Good Distribution Practice for Medical Devices (GDPMD)?

1. Submission of Request for Information (RFI)
2. Issuance of Quotation.
3. Submission of Application.
4. Stage 1 Audit.
5. Stage 2 Audit.
6. Recommendation & Approval.
7. Issuance of Certificate.
8. Surveillance and Recertification Audit.

What is establishment license?

Shop Establishment Certificate It is also called Shop License informally. The Shop Establishment registration is a state -based registration required while establishing a hotel, shop, or any commercial place. The validity of Shop Establishment License is for one year and it can be renewed every year.

What is MDA oximeter?

DESCRIPTION. Pulse Oximeter is an important and common device to check oxygen saturation (SpO2) and pulse rate. It’s a small, compact, simple, reliable and durable physiological monitoring device. Include the mainboard, OLED display and dry batteries.

How can I get Gdpmd in Malaysia?

GDPMD Is Not Just A Piece of Paper!

1. Step 1: Get GDPMD Certified. Decide on No of devices.
2. Step 2: Establishment License (With MDA)
3. Step 3: Product License (With MDA)
4. Step 4: Let’s Rock The Market!
5. Step 1: Get GDPMD Certified (estimated 1 month)
6. Step 2: Establishment License (estimated 3 months)
7. Step 3: Product License.

Who regulates medical device registration in Malaysia?

Medical device registration in Malaysia is regulated by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH). The MDA implements and enforces the Medical Device Act 2012 (Act 737).

How can Malaysia become a medical device industry hub?

“In order to position Malaysia as a medical device industry hub, it is essential to help our local manufacturers to reach for a higher level and become global champions. This requires the concerted efforts of all parties – from the manufacturers to the agencies and the government. We… 1.

What is medmedc@st?

MeDC@St is a web-based Online Application System for Establishment Licensing, Medical Device Registration and Export Permit. It is a centralized system where only one account needs to be created by an applicant to apply for Establishment Licensing , Medical Device