VenueTropicana Golf & Country Resort Petaling Jaya
Date20th November 2023
Attendance79 participants
Topic:
Understanding hybrid medical device type, process approval and Guidelines
Summary:
MMDA, in collaboration with SIRIM, successfully hosted a seminar on Hybrid Medical Device Type Approval. The event, held at Tropicana Golf & Country Resort, saw the participation of 79 attendees. The seminar focused on understanding hybrid medical device types, the approval process, and relevant guidelines.
Key topics covered included:
- Updates on hybrid medical device regulation
- Procedures for applying for type approval
- Requirements for MCMC labels and import permits
- Applicable regulations, guidance, and booklets
- Issues and challenges in registration for type approval and import permits
- Amendments to Type Approval
- SLP and import permit processes
- Special and conditional approvals · IT networking requirements and processes
This seminar provided valuable insights and practical guidance for professionals involved in the hybrid medical device sector.
