EMERGO SUMMARY OF KEY POINTS:

• The Malaysian MDA will allow qualifying medical device market applicants to sell their products in the country pending full regulatory approval through June 2018.
• MDA registrants that submitted applications on or before June 30, 2016 qualify for the extended moratorium.
• Companies that submitted MDA registration applications after June 30, 2016 must obtain full regulatory approval before Malaysian commercialization.

The Medical Device Authority (MDA), Malaysia’s medical device regulator, will extend a moratorium for companies that have registered for market access but not yet received approval so that they may continue selling in the country as their premarket reviews proceed.

According to the MDA announcement (link in Malay) and Emergo consultants in Kuala Lumpur, the moratorium has been extended to June 30, 2018 for medical device registrants that submitted applications to the regulator on or before June 30, 2016.

What the moratorium means for qualified MDA registrants

Companies that qualify for the MDA moratorium may continue using letters from the regulator acknowledging receipt of their applications as supporting documents in order to market their devices in Malaysia even though they have not yet received final approval. The extension of the moratorium will allow MDA staff to complete pending registration reviews and avoid device supply disruptions to healthcare providers, according to the agency.

Registrants whose market applications were submitted after June 30, 2016 do not qualify for the extension, and may only commercialize their devices in Malaysia once they obtain full registration from MDA.

Additional Malaysian medical device regulatory resources from Emergo:

• Malaysian registration consulting for medical device companies
• Malaysia Authorized Regulatory Representative in-country representation
• Whitepaper: Malaysian MDA medical device registration requirements
• Video overview: Malaysia’s medical device approval process