Asia-Pacific Roundup: Malaysia queries on requirements for medical device certificate applications

Malaysia’s Medical Device Authority (MDA) is seeking feedback on proposed changes to its guidance on the application requirements for certain certificates. MDA is planning to expand the guidance beyond export-only certificates of free sale (CFS) to cover manufacturing certificates.
The current version of the guidance, published in 2018, describes the process for applying for a CFS for an export-only medical device. MDA plans to expand the scope of the document, titling the draft second edition of the guidance “requirements for application of certificate of free sale, manufacturing certificate and certificate of free sale for export only medical devices.”
That expanded scope is reflected in a section that features tables of requirements for obtaining medical device certificates. The existing document features one table that lists requirements companies need to meet when filing for CFS for export-only medical devices. That table is largely unchanged in the proposed draft, but MDA has added two new tables that describe the requirements for CFS and manufacturing certificates.
Companies applying for a CFS need to provide a copy of the establishment license, registration certificate and details of the product covered by the filing. The requirements for manufacturing certificates include all the CFS materials, plus additional information such as a copy of the quality management system certificate. The list of requirements for export only CFS is much longer.
Other changes to the existing guidance include the addition of example fee calculations for CFS and manufacturing certificates, plus a new section on application amendments. The new section states that no amendments are allowed once a certificate is issued. Companies that want to make changes will need to submit a new application. The draft also features new annexes.
MDA is accepting feedback on the draft guidance until 13 January.
Draft Guidance





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