Medical Devices Consultancy

Medical Devices Consultancy

Shinteklogy Sdn Bhd (STK), the earliest company in Malaysia providing Local Authorized Representative services (LAR) and Product Registration advisory services to manufacturers worldwide.

We have been active in providing Medical Device Management System and Medical Device Regulations related training and consultancy services for the past 20 years. We specialize in guiding clients to comply with international medical regulations such as CE Mark & US FDA.

Our existence in the industry has given us the advantage to work closely with the Conformance Assessment Body and the Authority (i.e Malaysia Medical Device Authority). We receive first-hand information on all the latest development of the Medical Device Regulations in Malaysia.

We can provide a comprehensive support to our clients from developing Medical Device Management System until completion of the product registration process with the Authority.

In addition, SHINTEKLOGY also provides a range of other consultancy support services including Training and Audit services.

SHINKTEKLOGY provides consultation on medical devices for the following:

  • Establishment License Application
  • Medical Device Registration
  • Audit Service

Under Malaysia’s Medical Device Act and Regulations, any foreign medical device manufacturers without a licensed and registered office in Malaysia must elect a Local Authorized Representative (AR) to act as a liaison with the Medical Device Authority (MDA) of Malaysia.

SHINTEKLOGY is your best choice to act as an independent Local Authorized Representative. We have the expertise, experience and a successful track record for all medical device registration. We continuously monitor latest and up-to-date medical device regulations for an efficient and effective registration process.

As an ‘independent’ local representative, SHINTEKLOGY can reduce time spent managing regulatory matters and help to prevent any conflict of interest between the manufacturer, importer and distributor. We also act as a confidant for your proprietary information, which benefits your distributors to solely focus on sales and distribution and also gives you the advantage to change distributors anytime at your discretion.