EMERGO SUMMARY OF KEY POINTS:

• Malaysia’s MDA has clarified application requirements for medical device registration exemptions.
• The regulator has set 14-day timelines for reviewing and deciding upon exemption applications from device importers and manufacturers.

The Malaysian Medical Device Authority (MDA) has clarified which documents are required for manufacturers to apply for exemption from medical device registration requirements in the country.

The MDA’s list of forms and documents required for exemption applications pertain to the following circumstances under which such exemptions are permissible:

• Devices intended for demonstrations or marketing purposes
• Devices for educational uses
• Devices needed for clinical research or performance evaluation
• Custom-made devices
• Special-access devices

In addition, the MDA also exempts importers and manufacturers of qualifying devices from establishment license requirements.

Depending on the purpose of a particular device exemption, applicants should submit forms to the following MDA offices:

• For exemptions based on importing and/or supplying devices for clinical investigations, ci@mdb.gov.my.
• For demonstrative, custom-made and special-access devices, bpt@mdb.gov.my.

According to Emergo consultants in Kuala Lumpur, the MDA has set timeframes of 14 business days for assessing exemption applications and issuing decisions.

Related Malaysian medical device regulatory resources:

• Malaysian MDA medical device registration support
• Malaysia Authorized Regulatory Representative in-country representation
• Video overview: Malaysian medical device registration
• Whitepaper: Medical device registration and approval in Malaysia