GDPMD Certification is a mandatory requirement for the assurance of quality, safety and performance of medical devices during all stages of the medical device supply chain.

TECOLAB provides customers with GDPMD consultation prior to medical device registration.

Establishment License is a mandatory requirement by law, for the placement of medical devices in the Malaysian market. There are four types of Establishment License namely:

1.  License for Manufacturer
2. License for Authorized Representative
3. License for Importer
4. License for Distributor

TECOLAB assist customers with their Establishment License Applications.

Your medical device may fall under one of these classes:

• Class A: Low Risk Level
• Class B: Low-Moderate Risk Level
• Class C: High-Moderate Risk Level
• Class D: High Risk Level

Apart from classification, medical devices are also generally grouped into the following categories:

• Single
• Family
• System
• Set

TECOLAB readily assist customers to classify and group their products into the appropriate classes and grouping according to the product nature of application and risk evaluation.

Note: The actual classification of your medical device varies according to the manufacturer’s claim of product. Click here to learn more.

According to the Medical Device Authority (MDA), conformity assessments of medical devices are done to ensure the safety and good performances of these medical devices. The elements of a conformity assessment include:

• Conformity assessment of quality management system (QMS)
• Conformity assessment of post-market surveillance system (PMS)
• Conformity assessment of technical documentation
• Declaration of conformity (DoC)

Note: The level of conformity assessment varies according to the risk associated to the medical device.

Ideally, there are two types of medical device assessment namely:

1. Full Conformity Assessment (For Medical Devices Approved in Non-Recognized Countries by MDA)
2. Product Verification (For Medical Devices Approved in Recognized Countries by MDA; Australia, European Union, Canada, United States of America, and Japan.)

TECOLAB guides customers in preparing the technical documents required for product conformity assessment.

Let us know here if your product is to be registered in those 5 countries stated above or do they require a CE Mark.

TECOLAB assists customer with their medical device registration in the MeDC@St system.

Click here to find out more on how to register online.

Note: Application fee and registration fee of medical devices will be imposed upon registering your medical device.