A. MDA product registration for one (1) Class A medical device family. (per year) Preparation and review of the required registration documents and technical information. Submission to the Medical Device Authority (“MDA”) and liaison during the registration process. iElder to act as the Malaysian Authorised Representative, subject to execution of an AR agreement and receipt of complete manufacturer authorisation and supporting documents. Storage support for the registered products. Sales and distribution support under the 30% margin arrangement in Section 3. This is per year rate B. Authorised Representative Arrangement (Per year) The product registration will be submitted and held under iElder’s applicable establishment licence as the appointed AR. The manufacturer shall provide a valid Letter of Authorisation appointing iElder and execute the applicable AR agreement before submission. The manufacturer/customer remains responsible for the accuracy and completeness of product information, ongoing product compliance, and timely notification of any product, manufacturer, labelling, safety or regulatory change. Post-market surveillance, complaint handling, vigilance reporting, field safety corrective action, recall, renewal and change-notification work outside routine administration may be charged separately depending on the work required. The ongoing AR appointment is subject to iElder’s establishment licence remaining valid and the customer maintaining all agreed commercial and regulatory obligations.
