In Brief: Full Enforcement of Malaysian Medical Device Regulations Set for July 1, 2018
EMERGO SUMMARY OF KEY POINTS:
- Malaysian medical device registration rules will come into full force in July 2018.
- Companies currently using Acknowledgment Letters to sell their devices in Malaysia will need to obtain full registration by June 30, 2018.
The Malaysian Medical Device Authority (MDA) has given official notice that registration requirements under the country’s Medical Device Act 2012 will come fully into force on July 1, 2018.
According to the MDA notice (link in Malaysian), all registration applications submitted to MDA on or before June 30, 2016 must be completed by June 30, 2018.
Many companies previously marketing their devices in Malaysia using Acknowledgment Letters must therefore ensure that their MDA registration applications are processed in time in order to legally continue sales activities in the country.
As previously reported by Emergo, in late 2017 Malaysian authorities extended their moratorium on enforcement of the Medical Device Act 2012 to July 2018, allowing qualifying registrants to use Acknowledgment Letters from MDA to sell their products in the country while their applications underwent regulatory review.
Additional Malaysian medical device regulatory resources: