Medical Devices Registration

Some of the activities that are performed for the registration of medical devices include:

  • Compiling registration dossiers for various risk classes of devices and their variants.
  • Liaising with principals and the ministry to ensure prompt and complete documentation for the dossiers.
  • Guiding and liaising with principals/manufacturers on document requirements for local submission.
  • Submitting completed dossiers online under Medics (Singapore) or MedCast (Malaysia).
  • Corresponding with the ministry on regulatory matters concerning the devices.
  • Guide in grouping devices to minimize the number of submissions, thereby helping the company reduce costs.
  • Prioritizing dossier submissions before ministry deadlines for uninterrupted device sales.
  • Aiming to submit dossiers in time to benefit from early bird discounts, leading to substantial savings for your company.
  • Responding to ministry queries, including initial input requests during dossier screening.