EMERGO SUMMARY OF KEY POINTS:

• Malaysian regulators at the MDA have set two registration-related deadlines for companies whose market applications are still being processed.
• Late October 2017 and early January 2018 deadlines will impact Malaysian market registrants whose applications are still under regulatory or Conformity Assessment Body review.

Malaysian medical device market registrants should be aware of two key compliance deadlines coming in late 2017 and early 2018.

According to a recent notice (link in Malay) issued by the Malaysian Medical Device Authority (MDA), the two pertinent deadlines are:

• October 31, 2017: Deadline to complete registration applications in the MDA’s Medical Device Centralized Online System (MeDC@ST) online portal. Registrants whose applications are still being processed by their Conformity Assessment Bodies (CAB) will have to finalize their certifications and submit them to the MDA by this deadline.
• January 1, 2018: Deadline for obtaining official registration certificates from the MDA. Following this date, companies may no longer use acknowledgment letters to import and sell their devices in Malaysia.(Acknowledgment letters were issued to Malaysian market applicants that submitted their applications before June 30, 2016; companies may currently use these letters to commercialize their devices in Malaysia while the MDA reviews their registration submissions.

Emergo consultants in Kuala Lumpur anticipate that these deadlines will affect existing Malaysian market registrants more so than new market applicants, and have requested clarification from the MDA on how these deadlines will impact manufacturers whose registration applications are still under CAB review. We will provide updates on these issues as we learn them.

Related information on Malaysian medical device regulations:

• Malaysian MDA medical device registration support

• Malaysia Authorized Regulatory Representation in-country representation

• White paper: Malaysian medical device registration and approval

• Video overview: The MDA’s regulatory process for medical devices