Consultation
Consultation
MDA now offers a paid consultation service in an effort to assist the medical device industry to understand and comply with Malaysian medical device regulatory requirements. Any medical device stakeholders interested in obtaining consultation or information on medical device regulations are encouraged to join this session.
Who?
Open to individuals or small groups from any company or organization.
When?
During office hours. Specific time will be arranged accordingly.
Fee and Duration
The fee is based on the service selected.
- Pre-Medical Device Registration Submission (RM 600 - max 2 hours)
- Pre-CAB registration (RM 600 - max 2 hours)
- General Enquiries - according to the topic chosen (RM 100 for an hour)
Where?
1. Face-to-face consultation at MDA’s Meeting Rooms; OR
2. Online consultation (when physical consultation is not possible)
How?
1. Applicants can fill in the required information using the link HERE
2. Please complete and upload the template for list of questions for consultation (word format). ( CLICK HERE)
3. MDA will review the questions and schedule for the consultation based on officer’s availability.
3. Issuance of invoice via email after confirmation received.
3. Make payment.
(*Please be informed that payment for online consultation must be made 3 days prior to the consultation date. Once the payment has been received, we will email you the link to join the consultation session.)
4. Once payment is cleared, MDA will email the details of the consultation.
Scope
1. General medical device regulatory requirement enquiries.
2. Specific enquiries (Please specify in the application form).
Contact:
For any inquiries, please email to consultation [AT] mda [DOT] gov [DOT] my
Updated: 28th April 2022
