No penalty for medical industry players who are yet to register their equipment with MDA

PUTRAJAYA: The Health Ministry will not penalise any medical equipment industry player who has yet to register their equipment or their company with the Medical Devices Authority (MDA).
"We are giving them a certain amount of flexibility to be registered because the number of equipment to be registered is quite large. The MDA is working to register all of them," Health Minister Datuk Seri Dr S. Subramaniam said, adding that the ministry has made certain decisions for this to be done faster.
He was responding to an article in theSun today in which R. Nadeswaran in his column Citizen Nades said the Health Ministry has done nothing about procurement of critical life-saving equipment by the government from a company that has not completed formalities under the MDA as required by the Health Ministry.
Subramaniam said there are two processes for these companies.
"They firstly have to register their companies with the MDA. They then have to make sure that all their medical equipment meet the basic provisions of the Medical Devices Act," he added.
He said this will be a challenging task but asked for these industry players to bear with the ministry.
"Clearance for these companies will take a year, so we are working on it. This is the teething problem of anything you start first, there will be challenges, but I am confident that in the next few months we will be able to solve this problem," he said at a press conference in his office here today.
He also said that new machines from medical companies will have to go through the Good Distribution Practice for Medical Devices under the Medical Devices Act where they will have to meet the provisions set in the act.