TRAINING ON CLINICAL INVESTIGATION OF MEDICAL DEVICE

                        Date (Day)       : SEPTEMBER 12^TH AND 13^TH, 2022 (MONDAY AND TUESDAY)

                        Time                : 9.00 AM – 5.00 PM

                        Venue              : BILIK MERANTI, LEVEL 6, PRIMA 9, CYBERJAYA.

ELIGIBILITY

• Medical device establishments;
• Medical device industry representatives;
• Clinical research organization; and also
• Stakeholders in Malaysia.

OBJECTIVES

• Describe the basic concepts of medical device life cycle.
• Explain the regulatory pathway for clinical research in Malaysia.
• Explain the conduct of clinical investigation based on ISO 14155:2020.
• Describe the elements in preparing Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB).
• Explain the derivation of clinical evidence for general medical device and IVD medical devices for clinical evaluation.

ABOUT THE TRAINING COURSE

• Introduction on the medical device life cycle.
• Explanation on the Malaysia regulatory pathway for clinical research.
• Understanding best practices on conducting clinical investigation according to ISO 14155:2020.
• In depth understanding on clinical evaluation for general medical device and IVDs.
• Documentation preparation on submitting a notification of exemption from registration of medical devices for the purpose of device study that includes Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB).
• Understanding to the important aspects to be covered under clinical investigation plan (CIP) and investigator’s brochure (IB) documentation.

REGISTRATION & TRAINING FEE

Training fee per participant : RM 2,400.00

Application for the training shall be made via provided Registration Form by

Clicking HERE

Should you have any enquiries, please do not hesitate to contact the Training Secretariats:

 (trainingpackage@mda.gov.my) at 03-8230 0395 / 0240 / 0355 / 0211 / 0343

Updated: 18/82022