Q1: What are the main changes to registration in Malaysia?

JG: Currently, medical device registration is under a voluntary scheme. Under the Medical Device Regulations 2012, medical devices will have to undergo a conformity assessment before they are released into the Malaysian market.

To comply with legislation, authorized representatives, importers and distributors must have Good Distribution Practice for Medical Devices (GDPMD) in place.

Q2: When do these changes take effect? How should I prepare?

JG: The Medical Device Regulations 2012 will come into effect on July 1, 2013. The best way to prepare for these changes is to first, determine the classification and regulatory route of your product(s). Second, ensure that your product(s) complies with the new regulatory requirements. Third, register your product(s) before the deadline. However, a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.

Q3: Do I need to re-register my devices in Malaysia?

JG: Yes, if you’ve voluntarily registered your product in the past, you must re-register your medical device in the new database, the Medical Device Centralized Application System, to ensure compliance with the new regulatory requirements.

Q4: Can you point out an interesting point in the Malaysian registration process?

JG: In Malaysia, GDPMD is cheaper because it excludes sections of the ISO 13485, such as development and production evaluations, to focus more on the processes after the development of the product, such as distribution and post-marketing surveillance.

Q5: What is the greatest benefit of registration in Malaysia?

JG: The medical device market in Malaysia relies heavily on imported medical devices. Importation of medical devices has grown significantly over the past five years and is expected to continue to grow at a steady rate to meet the country’s healthcare needs.

Website Pop-Up - European Regulatory Representative Services