GDPMD Good Distribution Practice in Medical Device
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Frequently Asked Questions

Below are the frequently asked questions which we attempt to provide an answer. Should the answer not correct or require rephrasing, please provide your input at the forum.

Q: [How do I know whether I am selling medical device?]
A: [See Definition of Medical Device on the MDCD page >>Click here<<]

Q: [When will MDCD implement the new Medical Device Regulations?]
A: [1st of July 2013]

Q: [When should distributors obtained their Establishment Licence]
A: [Before 1st July 2014]

Q: [When should distributors start preparing for getting their Establishment Licence]
A: [Now, distributors need to set up a Quality Management System which complies to Good Distribution Practices as per MDCD guidelines, it takes time to get your staff to get familiarised with it, after that will need to be assessed by a Conformity Assessment Body, if passed will be eligible to apply for the licence.]

Q: [When should products be registered]
A: [Before 1st July 2015]

Q: [When should companies start preparing for the product registration]
A: [Now, there are a lot of work to be done before you can submit for registration. For excample: risk classification, groupings, clinical data, validation reports, conformity to essential priciples, declarations, stability studies, risk analysis reports, biocompatibility studes report, etc to be prepared in the manner required and Common Submission Dossier need to be written.]

Q: [Who are the Coformity Assessment Bodies?]
A: [These CAB are to be announced]

Q: [Without CAB how do we get our Quality Management System assessed?]
A: [Technically you cannot]

Q: [What happened if I missed the deadlines?]
A: [If you missed the deadline for Establishment Licence, you cannot distribute or import medical device, if you have not registered the product on time, you cannot put the medical device in Malaysia's market]