About Us
MedPros is the leading advisory firm in the medical device industry to meet the rapid changing demand in the market. We have been active in providing consultation and registration services related to Medical Device Regulations in Malaysia for the past 10 years. In order to specialize in guiding our clients to comply with medical regulations, we work closely with government authorities (i.e Malaysia Medical Device Authority) by receiving first-hand information on all the latest developments of Medical Device Regulations in Malaysia In accordance with the Malaysia Medical Device Act 2012 (Act 737).
Why Choose Us
Services
Good Distribution Practice Medical Device (GDPMD) Application
GDPMD is a set of guidelines and quality standards established to ensure the proper distribution and handling of medical devices in a company.
By establishing this standard, it helps to prevent the company from distributing substandard or counterfeit medical devices and enhance your regulatory compliance.
Establishment License Application (EL License)
EL license is required for Local Authorized Representative(AR), Importer, Distributor and other supply chain to legally operate medical device industry in Malaysia.
This license is the mandatory documentation prior to register their medical devices/products with the Malaysia Medical Device Authority (MDA).
Authorized Representative
The Malaysia Medical Device Regulations 2012 mandate that manufacturers based outside of Malaysia must designate a Local Authorized Representative to serve as an intermediary with Malaysian authorities.
MedPros offers provider as an expert and accredited Authorized Representative services. By choosing us as your independent representatives, you can maximize your distribution network by streamlining your device into the market.
Product Classification
It is important to determine the category of a product whether to fall under MDA department because different products require different regulatory applications.
MedPros will ensure our clients comply with the correct regulatory requirements to prevent unnecessary expenditures and minimize financial waste.
Conformity Assessment Application
It is the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with the essential principles. Two types services are offered:
By the way of Verification
By the way of Full Conformity Assessment
Medical Device Registration
Registering medical devices with Medical Device Authority is crucial to comply with legal obligations. MedPros help expedite and facilitate the registration process, enabling your business to prioritize entering the Malaysia market and seizing initial business opportunities.
Testimonials
Testimonial 1
Thanks to MedPros team to smoothen the regulatory process, we’ve successfully launched our products in market!
Testimonial 2
MedPros team is very spontaneous and efficient in handling my case and get approval, appreciate it!
Testimonial 3
MedPros team very professional in guiding us in the regulatory MDA that suit to our own business plan!
Testimonial 4
MedPros team really help us a lot in finding the solutions to solve all the issue raising, impressed with their good services given!