附錄1：醫療器材豁免清單（2/2）
（暫不需要申請進口推薦函）
級別 風險等級 所須附加文件 備註
A
低風險Low Risk
1.
首頁（Cover Letter）2.
廠家授權書(Letter of Authorization from owner or manufacturer)3.
產品說明（如需）Product Description (If necessary)4.
製造許可證或GMP證書之複印件Manufacturing License or GMP Certificate Copy5. ISO13485證書複印件（ISO 13485 Certificate Copy）
6.
完整標籤信息Complete Labeling information7.
當地公司之營業執照或公司註冊證印本Copy of business license of the local company orcertificate of incorporation
A級產品為檢查
手套、石膏、可 重複使用的手術 器材等…但實際 由FDA定奪。申 請時須附上所申 請進口之產品。B
低中等風險Low-Moderate Risk
1.
首頁（Cover Letter）2.
廠家授權書(Letter of Authorization from owner or manufacturer)3.
產品說明（如需）Product Description (If necessary)4.
製造許可證或GMP證書或EC證書Manufacturing License/GMP Certificate/EC certificate5. ISO13485證書複印件（ISO 13485 Certificate Copy）
6.
分析證書/符合性聲明，包括合規標準Certificate of Analysis/ Declaration of conformityincluding Compliance Standard
7.
產品安全聲明（Declaration of Product Safety）8.
製造流程（Manufacturing Process）9.
營銷許可證明（例如出口證明，自由銷售證書，營銷歷史）Evidence of MarketingApproval( Eg. Export certificate, Free sale certificate, Marketing History)
10.
風險分析及風險管理報告Risk Analysis and Risk Management Report11.
完整標籤信息Complete Labeling information12.
當地公司之營業執照或公司註冊證印本Copy of business license of the local company orcertificate of incorporation
備註:若申請之醫材為快速診段測試工具包(Rapid Diagnostic Test Kit)，則須備妥國家衛生 實驗室推薦函正本(National Health Laboratory Recommendation)。
產品風險等級由
FDA定奪，申請
時須附上所申請 進口之產品。須 提供樣品的數量，如附件3-5清單。
C
中等風險Moderate –High Risk
如同B器材所需文件；以及臨床評估報告（Clinical Evaluation Report ）D
高風險High Risk
附錄2.各類醫療器材申請進口所須附加之文件（1/2）
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Letter of Authorization Template
* You give authorization to this importer/distributor exclusively or not, if not please mention detail information. (Name of company, name of product, model)
Letterhead of Product Owner
Product owner (name) ……… authorized to Distributor/Importer (Myanmar), Address………..…
Authorized product list ……….
(Product name, Brand name, Model, Type, size, . . . )
Date
Validity – valid at least 3 year from the date of submission
Signature ………...
Full Name ………...
Designation ………...
Seal/Stamp ………...
Letter of Authorization
Forwarding
Product owner agree to assist Myanmar FDA with any request for information on the above medical devices.
Declaration of Product Safety Format
Letterhead of Local Importer/ Distributor
Date ………….
Declaration of Product Safety Forwarding
I, local Importer/ distributor, of the medical devices stated below, hereby declare for any safety issues globally associated with the use of medical device(s) when used as intended by Product Owner, in the last three years from (dd/mm/yyyy) to (dd,mm,yyyy).
- Any reported deaths
……….
- Any reported serious deterioration of health and
……….
- Any field safety corrective actions and recalls at the time of this application.
……….
I, applicant, agree to report to Myanmar FDA for any form of safety issues related with stated medical devices after importing to Myanmar.
I, applicant, clearly aware that any mis-conduct in reporting process may result in the cancellation of Import approval issued by Myanmar FDA.
Signature .……….
Full name .……….
Designation .……….
Company Stamp ...…………..
TEMPLATE FOR DECLARATION OF CONFORMITY
(from AMDD Pg-79,80)
[To be printed on Company Letterhead of Product Owner or Physical Manufacturer]
We hereby declare that the below mentioned medical devices have been classifed according to the classifcation rules and conform to the Essential Principles for Safety and Performance as laid out in the [state the applicable statute of the Member State].
Name and Address of Product Owner:
<Person responsible for manufacturing the medical device>
Name and Address of Physical Manufacturer:
<Person responsible for manufacturing the medical device>
Authorised Representative (if required by a particular Member State):
<Local authorised representative responsible for placing the medical device on the market of the ASEAN Member State>
Medical Device(s):
<e.g. medical device name and model number>
Risk Classification: e.g. Class B, rule
<Class of Medical device according to the classification rule, and the rule used to determine the classification>
Quality Management System Certificate:
<Certification Body and Certificate Number, issue date, expiry date>
Standards Applied:
<International standards; OR Regional Standard; OR See Attached Schedule for multiple standards>
This declaration of conformity is valid from <Day Month Year>
Authorised Signatory:
Name, Position Date
廠家授權書範本 產品安全聲明範本 符合性聲明
文件範本
47
附錄2.各類醫療器材申請進口所須附加之文件（2/2）
附錄3：緬甸登記生產醫療器材業業者
序 公司名稱 執照日期 到期日
1 Pharmaceutical Factory ( Inyanung ) 7 th June, 2017 6 th June, 2020
2 Myanmar Economic Corporation
( Single Use Syringe Factory, Hmawbi)
13 th March, 2017
(Renewal 5 th time) December, 2018
3 Myanmar Jick-Young Co.,ltd 19 th Dec, 2016
(Renewal 4 th time) September, 2019 4 Crown Medical Dressing Factory 12 th January, 2018 11 th January 2021
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