APPLICATION FORM FOR MARKETING AUTHORIZATION



KINGDOM OF CAMBODIAMINISTRY OF HEALTH NATION-RELIGION-KINGDIRECTORATE GENERAL OF HEALTH DEPARTMENT OF DRUGS AND FOOD APPLICATION FORM FOR MARKETING AUTHORIZATIONINFORMATION ON THE APPLICANT :Name: Address :Phone:Fax :Email:INFORMATION ON THE MANUFACTURER :Name: Address :Phone:Fax :Email:C- INFORMATION ON THE PRODUCT :Commercial Name :(Trade Name )Size/Type:Purpose of use :D- ATTACHED INFORMATION:Certificate of GMP or Certificate of ISO from the Country of OriginCertificate of Free Sale from the Country of OriginCertificate of Analysis from the Country of OriginTechnical Documenta- CSDTb- Declaration of Conformity Letterc- Letter of Authorization d- Dear Healthcare Professional LetterSamples or BookletDate:Title:Name :Signature:ANNEX 2TECHNICAL DOCUMENTS(I) (Common Submission Dossier Template) (CSDT) A- Executive Summary1-Overview2-Commercial marketing history3-Intended uses and indications4-Regulatory approval or marketing clearance obtained5-Status of pending regulatory approval6-Important safety or performance informationB-Relevant Essential Principles and Method Used to Demonstrate Conformity Essential Principles and Evidence of Conformity - Essential Principles of safety and Performance comprises of : - General requirements of safety and performance that apply to all medical device - Design and manufacturing requirements of safety and performance, some of which are relevant to each medical device- Manufacturer determines the applicable essential principles and demonstrates conformity to each applicable essential principle- Conformity to essential principles is documented in a checklist formatC- Device Description- Device description & features, -Intended use, -Indications of use- Instructions of use, -Contraindications, – Warnings, - Precautions - Potential adverse effects, - Alternative therapy, -Materials- Other relevant specifications, -Other descriptive informationD-Summary of Design Verification and Validation Documents- Pre-Clinical Studies- Clinical Evidence (Level of detail required will depend on class of device (Class B, C or D )E- Device LabelingF- Risk Analysis- Recommended: Conduct risk management activities according to ISO 14971:2007 - Provide risk management report containing details on risk analysis, risk evaluation, risk control conducted for the medical device.G- Manufacturer Information -Manufacturing Process(II)DECLARATION OF CONFORMITY[To be printed on Company Letterhead of Product Owner]Name and Address of Product Owner: .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Manufacturing Site: .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Medical Device(s): .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Risk Classification: e.g. Class B, rule .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Quality Management System Certificate:..................................................................................................................................................................................................................................................................................................................................................................................................................................................................Standards Applied: .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Authorised Signatory:___________________________ _____________________Name, Position Date(III)Letter of Authorisation [To be printed on Company Letterhead of Product Owner]To: [Regulatory Authority of Member State][Medical Device Centre][Medical Device Authority][Date]Dear Sir/Madam,Subject: Letter of Authorisation for [name of Registrant]We, [name of Product owner], as the Product owner, hereby authorise [name of Authorised Representative in a Member State], as the Authorised Representative to prepare and submit applications for the evaluation and registration of medical devices to the [name of Regulatory Authority of a Member State] on our behalf.This authorisation shall apply to the following medical devices:[List containing product names of medical devices]We also authorise [name of Authorised Representative in a Member State] to make declarations and to submit documents on our behalf, regarding the above medical devices, in support of this application. These declarations and submissions are made pursuant to the requirements of the ASEAN Medical Device Directive, the [state the applicable statute of the Member State] and any other applicable laws that may also be in force.Yours Sincerely,[Signature][Full Name and Title of Senior Company Official][Company stamp](IV)Dear Healthcare Professional Letter[To be printed on Company Letterhead of Product Owner]Name of product owner...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Name & Contact Details of the Authorized Representative...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Affected Medical Device Proprietary Name...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Affected Device Intended Use and Indications...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Subject Matter of the Letter...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Problem Identified & Description of Health Risk...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Suggested Actions & Recommendations...................................................................................................................................................................................................................................................................................................................................................................................................................................................................................Signatory for the Letter Signatory:___________________________ _____________________Name and Designation Date ................
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