馬來西亞醫療器材登記法規問題集 -

馬來西亞醫療器材登記法規問題集

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文章目錄 點擊收合

HLF-TW-10請問馬來西亞對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

HLF-TW-20外國公司要到馬來西亞銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

HLF-TW-30外國公司要到馬來西亞銷售醫療器材，可以指派馬來西亞公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

HLF-TW-40外國公司銷售到馬來西亞醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文除了馬來文外，其他哪種語文也可以？網頁？

HLF-TW-50外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文除了馬來文外，其他哪種語文也可以？網頁？

HLF-TW-60經過核准登記的醫療器材，進口到馬來西亞要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

HLF-TW-70馬來西亞醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

HLF-TW-80外國子公司進口醫療器材後，如果委託馬來西亞的經銷商銷售，經銷商需要醫療器材營業許可證嗎？假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

各國醫療器材登記法規問答集

HLF-TW-10
請問馬來西亞對於醫療器材的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

What are the categories of medical devices in Malaysia? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?

Evershine RD：

醫療器材管理局 (MDA) 是馬來西亞衛生部轄下的法定機構，旨在管理、規範醫療器材、其行業和活動。

醫療器材是指：

1. 製造商打算單獨或組合用於人類的任何儀器、裝置、器具、機器、器具、植入物、體外試劑或校準器、軟件、材料或其他類似、相關物品目的。

2. 疾病的診斷、預防、監測、治療或緩解。

3. 損傷的診斷、監測、治療、減輕或補償。

4. 解剖或生理過程的調查、替換或修改或支持。

5. 支持或維持生命。

6. 控制受孕。

7. 醫療器材消毒。

8. 通過對人體進行體外檢查，為醫療或診斷目的提供信息。

MDA規定製造商應對醫療器材進行適當分類，且當一項醫療器材適用多項等級時，則以最高等級為標準。
根據MDA提供的分類準則，可先將醫療器材分為非侵入性醫療器材、侵入性醫療器材、主動式醫療器材等項目，再依使用方式進行分類。另外，當企業或指定驗證機構（CAB）對醫療器材產品分類有所爭議時，企業可於爭議發生後的30日内通知MDA相關情形，MDA最晚則須於收到通知後的30日内告知企業其對該醫療器材分類的最終決定。

一般醫療器材與體外診斷醫療器材，依風險等級由低到高分為A、B、C、D。設備必須通過合格評定機構 (CAB) 對 B、C 和 D 類設備的製造商文檔進行簡要技術審查。ISO證書、CE證書等文件必須提交給CAB。
審核通過後，CAB將頒發證書。設備註冊的最終包括通用提交檔案模板 (CSDT)、CAB 證書和申請，必須以電子方式提交給 MDA 以供審查和批准。

1. A級：風險等級低

．須向泰國 FDA 申請製造或銷售許可。

．泰國政府機構得在必要情況下針對此分類的醫療器材進行測試與查驗。

．一般醫療器材：簡易手術器材、壓舌板、玻璃液體溫度計、檢查燈、簡易傷口敷料、氧氣面罩、聽診器、助行器等。

．體外診斷醫療器材：臨床化學分析儀，製備的選擇性培養基等。

2. B級：風險等級中低

．需向泰國 FDA 進行申報（提供產品規格資料、生產過程等）取得產品通知（product notification）後才能生產。

．一般醫療器材：皮下注射針頭、吸引設備、麻醉呼吸迴路、吸引器、外部骨骼生長模擬器、助聽器、水凝膠敷料、患者自控止痛、光療裝置、X 射線膠片等。

．體外診斷醫療器材：維生素B12，妊娠自檢，抗核抗體，尿液試紙等。

3. C級：風險等級中高

．需向泰國 FDA 進行申報（提供產品規格資料、生產過程等）取得產品通知（product notification）後才能生產。

．一般醫療器材：肺呼吸機、骨科植入物、嬰兒保溫箱、血氧器、血袋、隱形眼鏡消毒/清潔產品、深部傷口敷料、除顫器、放射治療設備、呼吸機等。

．體外診斷醫療器材：血糖自測，HLA 分型。PSA 篩查，風疹等。

4. D級：風險等級高

．生產或進口前需要向泰國 FDA 完整地註冊與申請產品許可。

．此類別的醫療器材均須通過泰國FDA的驗證。

．一般醫療器材：起搏器及其導線、植入式除顫器、植入式輸液泵、心臟瓣膜、宮內節育器、神經導管、血管假體、支架等。

．體外診斷醫療器材：HIV獻血者篩查，HIV血液診斷等。

Medical Device Authority (MDA) is a statutory body under the Ministry of Health Malaysia which was established under the Medical Device Authority Act 2012 (Act 738) to control, regulate medical device.

Medical device means:

1. Any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of—

2. Diagnosis, prevention, monitoring, treatment or alleviation of disease;

3. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

4. Investigation, replacement or modification, or support of the anatomy or of a physiological process;

5. Support or sustaining life;

6. Control of conception;

7. Disinfection of medical device; or

8. Providing information for the medical or diagnostic purposes by means of an in-vitro examination of specimens derived from the human body,

The MDA requires manufacturers to classify medical devices appropriately, and when more than one class applies to a medical device, the highest class is the standard.
According to the classification criteria provided by MDA, medical devices can be divided into non-invasive medical devices, invasive medical devices, active medical devices and other items, and then classified according to the way of use.
In addition, when an enterprise or a designated certification body (CAB) has a dispute over the classification of medical device products, the enterprise can notify the MDA of the relevant situation within 30 days after the dispute occurs, and the MDA must notify the enterprise within 30 days after receiving the notification at the latest its final decision on the classification of the medical device.

General medical equipment and in vitro diagnostic medical equipment are classified into A, B, C, and D according to the risk level from low to high.
Equipment must undergo a brief technical review of manufacturer documentation for Class B, C and D equipment through a Conformity Assessment Body (CAB). ISO certificate, CE certificate and other documents must be submitted to CAB. After the audit is passed, the CAB will issue a certificate.
The final device registration includes the Common Submission Dossier Template (CSDT), CAB certificate and application, which must be submitted electronically to the MDA for review and approval.

1. Level A: Low risk level

． Manufacture or sales authorization must be applied to the Thai FDA.

． Thai government agencies may conduct testing and inspections for medical devices in this category if necessary.

． General medical equipment: simple surgical equipment, tongue depressor, liquid-in-glass thermometer, examination lamp, simple wound dressing, oxygen mask, stethoscope, walking aid, etc.

． In vitro diagnostic medical equipment: clinical chemistry analyzers, prepared selective media, etc.

2. Level B: Medium to low risk level

． It is necessary to declare to the Thai FDA (provide product specification information, production process, etc.) and obtain a product notification before production.

． General medical equipment: hypodermic needles, suction devices, anesthesia breathing circuits, suction devices, exoskeleton growth simulators, hearing aids, hydrogel dressings, patient-controlled pain relief, phototherapy devices, X-ray films, etc.

． In vitro diagnostic medical equipment: vitamin B12, pregnancy self-test, antinuclear antibodies, urine test strips, etc.

3. Level C: Medium to high risk level

． It is necessary to declare to the Thai FDA (provide product specification information, production process, etc.) and obtain a product notification before production.

． General medical equipment: lung ventilators, orthopedic implants, infant incubators, oximeters, blood bags, contact lens disinfection/cleaning products, deep wound dressings, defibrillators, radiation therapy equipment, ventilators, etc.

． In vitro diagnostic medical equipment: blood glucose self-test, HLA typing. PSA screening, rubella, etc.

4. Class D: high risk level

． Before production or import, it is necessary to complete registration and application for product license with Thailand FDA.

． All medical devices in this category must be verified by the Thai FDA.

． General medical equipment: pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, intrauterine devices, nerve catheters, vascular prostheses, stents, etc.

． In vitro diagnostic medical equipment: HIV blood donor screening, HIV blood diagnosis, etc.

【參考連結】

https://portal.mda.gov.my/

https://portal.mda.gov.my/doc-list/legislation.html

HLF-TW-20
外國公司要到馬來西亞銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

If a foreign company wants to sell medical devices in Malaysia, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

需要由馬來西亞當地居民或於馬來西亞有永久住址/領有工作簽證之企業負責人申請經銷許可證。

經銷商申請許可證須符合醫療器材優良經銷規範（GDPMD），再交相關資料交由指定驗證機構（CAB）進行驗證。
CAB核發相關證明與報告確認經銷商符合資格要求後，該經銷商可透過MeDC@St系統申請經銷許可證。
許可證有效期限為自核發日起算三年，且最晚須於到期一年前申請再核發。

具備條件

1. 申請人為企業負責人：須為高階管理階級，且為馬來西亞居民，或於馬來西亞有永久住址或領有工作簽證之人。

2. 聯絡人：負責許可證申請程序相關聯絡。

3. 獲得驗證機構（CAB）品質管理認證，確認產品符合GDPMD的要求。

4. 非製造商或授權代理商之經銷者，須取得製造商或授權代理商之授權許可。

申請內容

1. 企業詳情

．企業類型：製造商/ 授權代理商/分銷商/進口商

．商業登記：商業登記編號

．機構名稱：詳細信息、聯繫方式

2. 負責人

．馬來西亞公民身份證

．非馬來西亞人須有護照、機構負責人簽署的負責人任命書/就業證

．聯繫人(如果與負責人不同，須提供詳細聯繫方式)

．質量管理體系（QMS）：如果QMS已註冊 CAB 認證，須註明製造商的 QMS ISO/ ISO 13485 或其他機構類型的 GDPMD，並提供 CAB 的名稱和註冊號。

3. 設立許可申請的證明

．下載設立許可證明書

．由負責人填寫、蓋章並簽署表格後打印在公司信箋上

．上傳填妥的證明表格

4. 申請提交

．預覽後提交申請表

5.申請表內容

．一般性資訊

．製造商資訊

．產品群組分類

．共同技術文件（Common Submission Dossier Template, CSDT）及補充文件

．上市後市場監督紀錄

．符合性聲明書

．產品登記認證

A distribution permit needs to be applied for by a local resident of Malaysia or the person in charge of a business with a permanent address/work visa in Malaysia.

Distributors applying for a license must comply with the Good Distribution Practice for Medical Devices (GDPMD), and then submit relevant information to a designated certification body (CAB) for verification.
After CAB issues relevant certificates and reports confirming that the dealer meets the eligibility requirements, the dealer can apply for a dealer license through the MeDC@St system.
The validity period of the license is three years from the date of issuance, and an application for re-issuance must be applied for at the latest one year before the expiry date.

Qualified

1. The applicant is the person in charge of the company: it must be a senior management class, and be a resident of Malaysia, or have a permanent address in Malaysia or a person with a work visa.

2. Liaison: Responsible for liaison with the license application process.

3. Obtain certification body (CAB) quality management certification to confirm that the product meets the requirements of GDPMD.

4. Distributors who are not manufacturers or authorized agents must obtain authorization from the manufacturer or authorized agents.

Application Contents

1. Company details

．Business Type: Manufacturer/AR/Distributor/Importer

．Business Registration: Business Registration No.

．Organization name: details, contact information

2. Responsible person

．Malaysian Citizen ID Card

．Non-Malaysians must have passport, appointment letter/employment card signed by the head of the agency

．Contact person (if different from the person in charge, contact details must be provided)

．Quality Management System (QMS): If the QMS is registered for CAB certification, the manufacturer’s QMS ISO/ISO 13485 or other agency type GDPMD must be indicated and the CAB’s name and registration number.

3. Proof of application for establishment license

．Download the establishment permit certificate

．The form is filled, stamped and signed by the person in charge and printed on the company letterhead

． Upload the completed supporting form

4. Application Submission

．Submit the application form after the preview

5. Application form content

． General Information

． Manufacturer Information

． Product group classification

． Common Submission Dossier Template (CSDT) and Supplementary Documents

． Post-listing market surveillance records

． Declaration of Conformity

． Product registration certification

【參考連結】

https://portal.mda.gov.my/medc-st.html

https://portal.mda.gov.my/industry/establishment-licence/how-to-apply-for-establishment-licence.html

HLF-TW-25

HLF-TW-30
外國公司要到馬來西亞銷售醫療器材，可以指派馬來西亞公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

If a foreign company wants to sell medical devices in Malaysia, can it assign a Malaysian company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

外國製造的醫療器材需由馬來西亞本地的授權代理商（Authorised Representative, AR）協助申請醫療器材登記、處理醫療器材產品進口、經銷等事宜。

授權代理商在申請許可證時，須先符合醫療器材優良經銷規範（Good Distribution Practice for Medical Devices, GDPMD），再交相關資料交由指定驗證機構（CAB）進行驗證。
在CAB核發相關證明與報告確認授權代理商之資格符合要求後，授權代理商可透過MeDC@St系統申請許可證。
許可證有效期限為自核發日起算三年，且最晚須於到期一年前申請再核發。

具備資料

1.申請人為企業負責人：須為高階管理階級，且為馬來西亞居民，或於馬來西亞有永久住址或領有工作簽證之人。

2.聯絡人：負責許可證申請程序相關聯絡。

3.獲得驗證機構（CAB）品質管理認證，確認產品符合GDPMD要求。

4.製造商的授權許可。

申請內容

1. 企業詳情

．企業類型：製造商/ 授權代理商/分銷商/進口商

．商業登記：商業登記編號

．機構名稱：詳細信息、聯繫方式

2. 負責人

．馬來西亞公民身份證

．非馬來西亞人須有護照、機構負責人簽署的負責人任命書/就業證

．聯繫人(如果與負責人不同，須提供詳細聯繫方式)

．質量管理體系（QMS）：製造商的 QMS ISO/ ISO 13485 或其他機構類型的 GDPMD，並提供 CAB 的名稱和註冊號。

3. 設立許可申請的證明

．下載設立許可證明書

．由負責人填寫、蓋章並簽署表格後打印在公司信箋上

．上傳填妥的證明表格

4. 申請提交

．預覽後提交申請表

5.申請表內容

．一般性資訊

．製造商資訊

．產品群組分類

．共同技術文件（Common Submission Dossier Template, CSDT）及補充文件

．上市後市場監督紀錄

．符合性聲明書

．產品登記認證

製造商、授權代表(AR)應建立上市後監督系統(Post-market Surveillance System, PMS)追蹤銷售紀錄、客戶意見紀錄、負責不良反應通報等，每家機構都應向當局報告在馬來西亞境內外發生的涉及其醫療器材的任何事件。
馬來西亞註冊的醫療器材，企業應調查事故原因並進行現場糾正，必要時採取行動，以防止事件再次發生，以確保安全和醫療器材性能。

For medical equipment manufactured in foreign countries, a local Authorised Representative (AR) in Malaysia should assist in applying for medical equipment registration, and handling matters such as import and distribution of medical equipment products.

When an authorized agent applies for a license, it must first comply with the Good Distribution Practice for Medical Devices (GDPMD), and then submit the relevant information to the Designated Verification Body (CAB) for verification.
After CAB issues relevant certificates and reports confirming that the qualifications of authorized agents meet the requirements, authorized agents can apply for licenses through the MeDC@St system.
The validity period of the license is three years from the date of issuance, and the application for re-issuance must be applied for one year before the expiration date.

Qualified

1. The applicant is the person in charge of the company: it must be a senior management class, and be a resident of Malaysia, or have a permanent address in Malaysia or a person with a work visa.

2. Liaison: Responsible for liaison with the license application process.

3. Obtain certification body (CAB) quality management certification to confirm that the product meets the requirements of GDPMD.

4. Manufacturer’s license.

Application Contents

1. Company details

．Business Type: Manufacturer/AR/Distributor/Importer

．Business Registration: Business Registration No.

．Organization name: details, contact information

2. Responsible person

．Malaysian Citizen ID Card

．Non-Malaysians must have passport, appointment letter/employment card signed by the head of the agency

．Contact person (if different from the person in charge, contact details must be provided)

．Quality Management System (QMS): Manufacturer’s QMS ISO/ISO 13485 or other agency type GDPMD must be indicated and the CAB’s name and registration number.

3. Proof of application for establishment license

．Download the establishment permit certificate

．The form is filled, stamped and signed by the person in charge and printed on the company letterhead

． Upload the completed supporting form

4. Application Submission

．Submit the application form after the preview

5. Application form content

． General Information

． Manufacturer Information

． Product group classification

． Common Submission Dossier Template (CSDT) and Supplementary Documents

． Post-listing market surveillance records

． Declaration of Conformity

． Product registration certification

Manufacturers, Authorized Representatives (AR) should establish a Post-market Surveillance System (PMS) to track sales records, customer opinion records, and be responsible for reporting adverse reactions. to any incident involving its medical equipment.
For medical equipment registered in Malaysia, businesses should investigate the cause of the accident and make on-site corrections, taking action if necessary to prevent the incident from recurring to ensure the safety and performance of the medical equipment.

【參考連結】

https://portal.mda.gov.my/medc-st.html

https://portal.mda.gov.my/doc-list/guidance-document.html

HLF-TW-35

HLF-TW-40
外國公司銷售到馬來西亞醫療器材本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了馬來文外，其他哪種語文也可以？網頁？

Do foreign companies need to apply for an approval before importing medical devices sold to Malaysia?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to Malaysian, which other languages are allowed? Website?

Evershine RD：

外國製造的醫療器材需由馬來西亞本地的授權代理商（Authorised Representative, AR）協助申請醫療器材登記、處理醫療器材產品進口、經銷等事宜。

具備資料

1.申請人為企業負責人：須為高階管理階級，且為馬來西亞居民，或於馬來西亞有永久住址或領有工作簽證之人。

2.聯絡人：負責許可證申請程序相關聯絡。

3.獲得驗證機構（CAB）品質管理認證，確認產品符合GDPMD要求。

4.製造商的授權許可。

申請內容

1. 企業詳情

．企業類型：製造商/ 授權代理商/分銷商/進口商

．商業登記：商業登記編號

．機構名稱：詳細信息、聯繫方式

2. 負責人

．馬來西亞公民身份證

．非馬來西亞人須有護照、機構負責人簽署的負責人任命書/就業證

．聯繫人(如果與負責人不同，須提供詳細聯繫方式)

．質量管理體系（QMS）：製造商的 QMS ISO/ ISO 13485 或其他機構類型的 GDPMD，並提供 CAB 的名稱和註冊號。

3. 設立許可申請的證明

．下載設立許可證明書

．由負責人填寫、蓋章並簽署表格後打印在公司信箋上

．上傳填妥的證明表格

4. 申請提交

．預覽後提交申請表

5.申請表內容

．一般性資訊

．製造商資訊

．產品群組分類

．共同技術文件（Common Submission Dossier Template, CSDT）及補充文件

．上市後市場監督紀錄

．符合性聲明書

．產品登記認證

註冊醫療器材應標有馬來西亞醫療器材註冊號，並應在醫療器材註冊之日起 6 個月內進行。

鼓勵使用註冊證上的二維碼標示醫療器材註冊號。

允許的格式示例：

1. MDA註冊。編號 xxxxxxx

2. 在 MDA GXXXXX 註冊

3. 註冊號 Gxxxxxxx

4. Gxxxxxxx馬來西亞註冊。

5. 編號 XXXXXXX

6. 醫療器材註冊號 XXXXXXX

7. MDA GXXXXX

注意事項：

1. 醫療器材的標籤應清晰、永久且顯眼。

2. 標籤的媒介、格式、內容、可讀性和位置應適合特定設備、其預期目的以及預期用戶的技術知識、經驗、教育或培訓。

3. 所有家用設備應隨附紙本標籤。

4. 風險分析中確定的任何殘餘風險應在標籤中反映為禁忌症或警告。

5. 標籤可以通過多種媒體和多種方式提供給用戶，例如印刷文件、設備中的顯示屏、製造商的網站以及磁性或光學媒體。無論採用何種媒體或手段，信息都應針對預期的用戶群體。

6. 符合醫療器材法和法規的標籤可以在進口或製造後進行，但要在投放市場之前進行。標識內容應當按照醫療器材註冊時報送主管部門的規定執行。批號、批號或序列號、生產日期和有效期不得過度標註。

標籤位置

1. 在可行和適當的情況下，應在醫療器材本身和/或每個單元的包裝（初級包裝）上提供識別和安全使用醫療器材所需的資訊，和/或多種醫療器材的包裝（二級包裝）。如果這樣做不可行或不合適，則可在隨附的傳單、手冊、包裝插頁等中列出資訊。

2. 醫療器材註冊號、製造商/授權代表詳細信息和二維碼（如果有）應位於客戶/用戶在銷售點可以看到的位置。

3. 對於因醫療器材單獨包裝不實用而被包裝在一起的醫療器材，標籤應作為單張或多張隨附傳單、包裝插頁、文件或其他介質提供

4. 如果向單個用戶和/或地點提供多個醫療器材或一起包裝，則可以僅提供一份標籤副本，但應根據要求提供更多副本。

5. 對於標籤上提供的資訊，應在標籤上提供馬來西亞語翻譯。

格式

1. 標籤格式應符合適用的醫療器材標籤國際標準。

2. 鼓勵使用國際公認的符號，前提是醫療器材安全不會因患者或用戶缺乏理解而受到影響。

語言

1. 家用醫療器材必須使用馬來西亞語。

2. 其他類型的醫療器材標籤應使用英文。

3. 必要時可使用其他語言。

4.應提供馬來西亞語翻譯。

標籤內容

1.使用戶能夠識別的醫療器材的詳細信息，包括器材名稱（品牌名稱、通用名稱和指定名稱）、型號和標識號

2.批號/批號（例如一次性使用的醫療器材或試劑）或序列號（例如電動醫療器材）的指示，以利採取適當的行動追踪和召回醫療器材設備。

3.明確指示醫療器材可以安全使用的日期，至少以年和月表示，根據醫療器材的類型，註明製造日期。

4.必要時，首次打開主容器後的儲存條件和保質期，以及工作溶液的儲存條件和穩定性。

5.製造商和授權代理商（如果是外國製造商）的名稱、地址和聯繫方式 (電子郵件和/或電話號碼和/或網站地址)，以獲得技術上的援助。

6.有關醫療器材的技術細節，例如：器材規格/配方、顏色、尺寸、兼容性等。

7.醫療器材的描述和預期用途。

8.醫療器材使用說明。

9.對安全使用醫療器材的任何不良副作用、限制、警告和/或預防措施。

10.醫療器材的任何必要的上市後服務需求。

11.如果適用並基於風險評估需附上處置信息（例如：感染或微生物危害、環境危害；物理危害）。

Qualified

1. The applicant is the person in charge of the company: it must be a senior management class, and be a resident of Malaysia, or have a permanent address in Malaysia or a person with a work visa.

2. Liaison: Responsible for liaison with the license application process.

3. Obtain certification body (CAB) quality management certification to confirm that the product meets the requirements of GDPMD.

4. Manufacturer’s license.

Application Contents

1. Company details

．Business Type: Manufacturer/AR/Distributor/Importer

．Business Registration: Business Registration No.

．Organization name: details, contact information

2. Responsible person

．Malaysian Citizen ID Card

．Non-Malaysians must have passport, appointment letter/employment card signed by the head of the agency

．Contact person (if different from the person in charge, contact details must be provided)

．Quality Management System (QMS): Manufacturer’s QMS ISO/ISO 13485 or other agency type GDPMD must be indicated and the CAB’s name and registration number.

3. Proof of application for establishment license

．Download the establishment permit certificate

．The form is filled, stamped and signed by the person in charge and printed on the company letterhead

． Upload the completed supporting form

4. Application Submission

．Submit the application form after the preview

5. Application form content

． General Information

． Manufacturer Information

． Product group classification

． Common Submission Dossier Template (CSDT) and Supplementary Documents

． Post-listing market surveillance records

． Declaration of Conformity

． Product registration certification

Registration of a medical device should be marked with the Malaysian Medical Device Registration Number and should be done within 6 months from the date of registration of the medical device.
It is encouraged to use the QR code on the registration certificate to indicate the registration number of the medical device.

Examples of allowed formats:

1. MDA registration. No. xxxxxxx

2. Register with MDA GXXXXX

3. Registration number Gxxxxxxx

4. Gxxxxxxx registered in Malaysia.

5. Number XXXXXXX

6. Medical Device Registration Number XXXXXXX

7. MDA GXXXXX

Notes:

1. Labels for medical devices should be clear, permanent, and conspicuous.

2. The medium, format, content, readability and location of the label should be appropriate for the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user.

3. All household equipment should be accompanied by paper labels.

4. Any residual risk identified in the risk analysis should be reflected in the labeling as a contraindication or warning.

5. Labels can be provided to users in a variety of media and in a variety of ways, such as printed documents, displays in equipment, manufacturers’ websites, and magnetic or optical media.
Regardless of the medium or means used, the message should be targeted to the intended user group.

6. Labelling in compliance with medical device laws and regulations can be carried out after importation or manufacture, but before placing on the market.
The content of the logo shall be carried out in accordance with the provisions of the competent department when the medical device is registered. Lot numbers, batch or serial numbers, dates of manufacture and expiration dates must not be overly marked.

Label position

1. Where feasible and appropriate, the information needed to identify and safely use the medical device should be provided on the medical device itself and/or on the packaging of each unit (primary packaging), and/or the packaging of multiple medical devices (2. grade packaging).
If this is not feasible or appropriate, the information can be listed in accompanying leaflets, brochures, package inserts, etc.

2. The medical device registration number, manufacturer/authorized representative details and QR code (if any) should be located where the customer/user can see it at the point of sale.

3. For medical devices that are packaged together because it is impractical to package the medical devices individually, the label shall be provided as a single or multiple accompanying leaflets, package inserts, documents, or other media

4. If multiple medical devices are provided or packaged together to a single user and/or location, only one copy of the label may be provided, but additional copies should be provided upon request.

5. For the information provided on the label, a Malay translation shall be provided on the label.

Format

1. The label format shall conform to applicable international standards for medical device labelling.

2. The use of internationally recognized symbols is encouraged, provided that medical device safety is not compromised by lack of understanding by patients or users.

Language

1. Home medical equipment must be in Malay.

2. Labels for other types of medical equipment should be in English.

3. Other languages may be used when necessary.

4. A Malay translation shall be provided.

Label content

1. Details of the medical device that enables the user to identify, including the device name (brand name, generic name and designated name), model and identification number

2. Lot/Lot Number (e.g. single-use medical devices or reagents) or serial number (e.g. electrical medical devices) indication to facilitate appropriate action to trace and recall medical devices.

3. A clear indication of the date the medical device is safe to use, at least in years and months, and, depending on the type of medical device, the date of manufacture.

4. If necessary, the storage conditions and shelf life after opening the main container for the first time, and the storage conditions and stability of the working solution.

5. Name, address and contact details (email and/or phone number and/or website address) of the manufacturer and AR (if foreign manufacturer) for technical assistance.

6. Technical details about medical devices, such as: device specifications/formulas, colors, sizes, compatibility, etc.

7. Description and intended use of the medical device.

8. Instructions for use of medical equipment.

9. Any adverse side effects, limitations, warnings and/or precautions for the safe use of the medical device.

10. Any necessary post-market service needs for medical devices.

11. Attach disposal information if applicable and based on risk assessment (e.g. infectious or microbiological hazards, environmental hazards; physical hazards).

【參考連結】

https://portal.mda.gov.my/doc-list/guidance-document.html

https://portal.mda.gov.my/medc-st.html

HLF-TW-45

HLF-TW-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了馬來文外，其他哪種語文也可以？網頁？

Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical device packaging and labeling require prior approval?
In addition to Malaysian, which other languages are allowed? Website?

Evershine RD：

外國製造的醫療器材需由馬來西亞本地的授權代理商（Authorised Representative, AR）協助申請醫療器材登記、處理醫療器材產品進口、經銷等事宜。

具備資料

1.申請人為企業負責人：須為高階管理階級，且為馬來西亞居民，或於馬來西亞有永久住址或領有工作簽證之人。

2.聯絡人：負責許可證申請程序相關聯絡。

3.獲得驗證機構（CAB）品質管理認證，確認產品符合GDPMD要求。

4.製造商的授權許可。

申請內容

1. 企業詳情

．企業類型：製造商/ 授權代理商/分銷商/進口商

．商業登記：商業登記編號

．機構名稱：詳細信息、聯繫方式

2. 負責人

．馬來西亞公民身份證

．非馬來西亞人須有護照、機構負責人簽署的負責人任命書/就業證

．聯繫人(如果與負責人不同，須提供詳細聯繫方式)

．質量管理體系（QMS）：製造商的 QMS ISO/ ISO 13485 或其他機構類型的 GDPMD，並提供 CAB 的名稱和註冊號。

3. 設立許可申請的證明

．下載設立許可證明書

．由負責人填寫、蓋章並簽署表格後打印在公司信箋上

．上傳填妥的證明表格

4. 申請提交

．預覽後提交申請表

5.申請表內容

．一般性資訊

．製造商資訊

．產品群組分類

．共同技術文件（Common Submission Dossier Template, CSDT）及補充文件

．上市後市場監督紀錄

．符合性聲明書

．產品登記認證

註冊醫療器材應標有馬來西亞醫療器材註冊號，並應在醫療器材註冊之日起 6 個月內進行。
鼓勵使用註冊證上的二維碼標示醫療器材註冊號。

允許的格式示例：

1. MDA註冊。編號 xxxxxxx

2. 在 MDA GXXXXX 註冊

3. 註冊號 Gxxxxxxx

4. Gxxxxxxx馬來西亞註冊。

5. 編號 XXXXXXX

6. 醫療器材註冊號 XXXXXXX

7. MDA GXXXXX

注意事項：

1. 醫療器材的標籤應清晰、永久且顯眼。

2. 標籤的媒介、格式、內容、可讀性和位置應適合特定設備、其預期目的以及預期用戶的技術知識、經驗、教育或培訓。

3. 所有家用設備應隨附紙本標籤。

4. 風險分析中確定的任何殘餘風險應在標籤中反映為禁忌症或警告。

標籤位置

2. 醫療器材註冊號、製造商/授權代表詳細信息和二維碼（如果有）應位於客戶/用戶在銷售點可以看到的位置。

3. 對於因醫療器材單獨包裝不實用而被包裝在一起的醫療器材，標籤應作為單張或多張隨附傳單、包裝插頁、文件或其他介質提供

4. 如果向單個用戶和/或地點提供多個醫療器材或一起包裝，則可以僅提供一份標籤副本，但應根據要求提供更多副本。

5. 對於標籤上提供的資訊，應在標籤上提供馬來西亞語翻譯。

格式

1. 標籤格式應符合適用的醫療器材標籤國際標準。

2. 鼓勵使用國際公認的符號，前提是醫療器材安全不會因患者或用戶缺乏理解而受到影響。

語言

1. 家用醫療器材必須使用馬來西亞語。

2. 其他類型的醫療器材標籤應使用英文。

3. 必要時可使用其他語言。

4.應提供馬來西亞語翻譯。

標籤內容

1.使用戶能夠識別的醫療器材的詳細信息，包括器材名稱（品牌名稱、通用名稱和指定名稱）、型號和標識號

2.批號/批號（例如一次性使用的醫療器材或試劑）或序列號（例如電動醫療器材）的指示，以利採取適當的行動追踪和召回醫療器材設備。

3.明確指示醫療器材可以安全使用的日期，至少以年和月表示，根據醫療器材的類型，註明製造日期。

4.必要時，首次打開主容器後的儲存條件和保質期，以及工作溶液的儲存條件和穩定性。

5.製造商和授權代理商（如果是外國製造商）的名稱、地址和聯繫方式 (電子郵件和/或電話號碼和/或網站地址)，以獲得技術上的援助。

6.有關醫療器材的技術細節，例如：器材規格/配方、顏色、尺寸、兼容性等。

7.醫療器材的描述和預期用途。

8.醫療器材使用說明。

9.對安全使用醫療器材的任何不良副作用、限制、警告和/或預防措施。

10.醫療器材的任何必要的上市後服務需求。

11.如果適用並基於風險評估需附上處置信息（例如：感染或微生物危害、環境危害；物理危害）。

Qualified

1. The applicant is the person in charge of the company: it must be a senior management class, and be a resident of Malaysia, or have a permanent address in Malaysia or a person with a work visa.

2. Liaison: Responsible for liaison with the license application process.

3. Obtain certification body (CAB) quality management certification to confirm that the product meets the requirements of GDPMD.

4. Manufacturer’s license.

Application Contents

1. Company details

．Business Type: Manufacturer/AR/Distributor/Importer

．Business Registration: Business Registration No.

．Organization name: details, contact information

2. Responsible person

．Malaysian Citizen ID Card

．Non-Malaysians must have a passport, appointment letter/employment card signed by the head of the agency

．Contact person (if different from the person in charge, contact details must be provided)

．Quality Management System (QMS): Manufacturer’s QMS ISO/ISO 13485 or other agency type GDPMD must be indicated and the CAB’s name and registration number.

3. Proof of application for an establishment license

．Download the establishment permit certificate

．The form is filled, stamped and signed by the person in charge and printed on the company letterhead

． Upload the completed supporting form

4. Application Submission

．Submit the application form after the preview

5. Application form content

． General Information

． Manufacturer Information

． Product group classification

． Common Submission Dossier Template (CSDT) and Supplementary Documents

． Post-listing market surveillance records

． Declaration of Conformity

． Product registration certification

Examples of allowed formats:

1. MDA registration. No. xxxxxxx

2. Register with MDA GXXXXX

3. Registration number Gxxxxxxx

4. Gxxxxxxx registered in Malaysia.

5. Number XXXXXXX

6. Medical Device Registration Number XXXXXXX

7. MDA GXXXXX

Notes:

1. Labels for medical devices should be clear, permanent, and conspicuous.

3. All household equipment should be accompanied by paper labels.

4. Any residual risk identified in the risk analysis should be reflected in the labeling as a contraindication or warning.

6. Labelling in compliance with medical device laws and regulations can be carried out after importation or manufacture, but before placing on the market.
The content of the logo shall be carried out in accordance with the provisions of the competent department when the medical device is registered.
Lot numbers, batch or serial numbers, dates of manufacture and expiration dates must not be overly marked.

Label position

2. The medical device registration number, manufacturer/authorized representative details and QR code (if any) should be located where the customer/user can see it at the point of sale.

4. If multiple medical devices are provided or packaged together to a single user and/or location, only one copy of the label may be provided, but additional copies should be provided upon request.

5. For the information provided on the label, a Malay translation shall be provided on the label.

Format

1. The label format shall conform to applicable international standards for medical device labelling.

2. The use of internationally recognized symbols is encouraged, provided that medical device safety is not compromised by lack of understanding by patients or users.

Language

1. Home medical equipment must be in Malay.

2. Labels for other types of medical equipment should be in English.

3. Other languages may be used when necessary.

4. A Malay translation shall be provided.

Label content

1. Details of the medical device that enables the user to identify, including the device name (brand name, generic name and designated name), model and identification number

2. Lot/Lot Number (e.g. single-use medical devices or reagents) or serial number (e.g. electrical medical devices) indication to facilitate appropriate action to trace and recall medical devices.

3. A clear indication of the date the medical device is safe to use, at least in years and months, and, depending on the type of medical device, the date of manufacture.

4. If necessary, the storage conditions and shelf life after opening the main container for the first time, and the storage conditions and stability of the working solution.

5. Name, address and contact details (email and/or phone number and/or website address) of the manufacturer and AR (if foreign manufacturer) for technical assistance.

6. Technical details about medical devices, such as: device specifications/formulas, colors, sizes, compatibility, etc.

7. Description and intended use of the medical device.

8. Instructions for use of medical equipment.

9. Any adverse side effects, limitations, warnings and/or precautions for the safe use of the medical device.

10. Any necessary post-market service needs for medical devices.

11. Attach disposal information if applicable and based on risk assessment (e.g. infectious or microbiological hazards, environmental hazards; physical hazards).

【參考連結】

https://portal.mda.gov.my/doc-list/guidance-document.html

https://portal.mda.gov.my/medc-st.html

HLF-TW-55

HLF-TW-60
經過核准登記的醫療器材，進口到馬來西亞要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

What documents are required when importing approved medical devices into Malaysia?
What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

要將貨物進口到馬來西亞，需要向馬來西亞皇家海關署（JKDM）申報、繳納關稅/稅款的進口稅、消費稅、銷售稅。

1.海關申報：所有進口到馬來西亞的貨物必須通過以下方式擇一申報

．指定報關員

．自我聲明(AEO 計劃 – AEO 門戶)

．直接用戶

2. 商品分類：進口商需要獲得對要進口到馬來西亞的商品的確認通過獲取貨物的正確關稅代碼是否需要繳納任何關稅/稅款。

3. 檢查物品是否為受控商品或進口違禁品：

．檢查擬進口的貨物是否為管制貨物或受當局禁止或限制進口的貨物。

．確認進口之前獲得許可/批准。

4. 申報和準備海關放行文件：每個進口商應在貨物抵達或抵達馬來西亞時，親自或由其代理人對進口貨物進行完整和真實的申報。

．電子報關單

．提交進口許可證(電子檔案或副本)

．提單/空運單

．發票(採購訂單或信用證)

．裝箱單

．原產國證明

．其他相關文件(檢驗證書、分析證書、成分證書、清真證書、產品規格證書等)

5. 貨物檢驗：JKDM保留檢查貨物以確保進口符合法律法規的權利。

6. 繳納關稅/稅款進口：貨物的應付關稅/稅款必須由進口商在貨物到達時支付。可以通過櫃檯或電子支付。

7. 海關批准

8. 海關放行

9. 保存文檔：進口記錄在馬來西亞保存七年

To import goods into Malaysia, import duty, excise duty, sales tax is required to be declared to the Royal Malaysian Customs Department (JKDM) and paid for duties/taxes.

1. Customs declaration: All goods imported into Malaysia must be declared through one of the following methods

．Designated Customs Broker

．Self Declaration (AEO Programme – AEO Portal)

．Direct users

2. Commodity classification: The importer needs to obtain confirmation of the goods to be imported into Malaysia by obtaining the correct tariff code of the goods if any duties/taxes are to be paid.

3. Check if the item is a controlled commodity or an imported contraband:

．Check whether the goods to be imported are regulated goods or goods whose importation is prohibited or restricted by the authorities.

．Confirm permission/approval prior to import.

4. Declaration and preparation of customs release documents: Each importer shall make a complete and true declaration of the imported goods in person or by his agent upon arrival or arrival in Malaysia.

． Electronic customs declaration

． Submit import license (electronic file or copy)

．Bill of Lading / Air Waybill

．Invoice (Purchase Order or Letter of Credit)

．Packing List

．Certificate of country of origin

．Other relevant documents (inspection certificate, analysis certificate, composition certificate, halal certificate, product specification certificate, etc.)

5. Goods inspection: JKDM reserves the right to inspect the goods to ensure that the imports comply with laws and regulations.

6. Pay Duties/Taxes Import: Duties/taxes payable on the goods must be paid by the importer upon arrival of the goods. Payment can be made over the counter or electronically.

7. Customs Approval

8. Customs release

9. Preservation of documents: Import records are kept in Malaysia for seven years

【參考連結】

http://www.customs.gov.my/en/pages/main.aspx

HLF-TW-70
馬來西亞醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

醫療器材優良經銷規範（Good Distribution Practice for Medical Devices, GDPMD）：欲在馬來西亞銷售的醫療器材皆需符合GDPMD，並由指定驗證機構（CAB）進行驗證。所需文件：

1. 企業的概況、活動/運營、對醫療器材監管要求的遵守情況以及企業的義務，包括那些外包流程或活動/運營

2. GDPMD 監管合規系統的範圍，包括任何排除和/或不適用的細節和理由

3.醫療器材及其合規狀況

4.系統要求的程序及其參考

5. 企業為確保合規流程的有效規劃、操作和控制所需的文件

6. 監管合規系統要求的記錄

7. 活動場所、人員、醫療器材合格評定和註冊

8. 對 GDPMD 監管合規體系範圍內指定的每種醫療器材如何滿足相關和適用監管要求的詳細描述

9. 對於其處理的每種類型的醫療器材，企業應建立並維護文件，其中包含定義

．產品規格和安裝

．完整的分發過程以及安裝服務。

10. GDPMD 監管合規系統的記錄必須清晰易讀、易於識別和檢索

11.記錄需要保留一段時間

．依據相關法規要求

．至少相當於醫療器材產品的使用壽命或自醫療器材上市之日起不少於兩年

質量管理體系（QMS）

於泰國販售的醫療器材製造商應通過 ISO 13485 認證，

1. A級：完整的質量管理體系或無設計和開發控制，製造商應選擇其認為最合適的一種。

2. B級：完整的質量管理體系或無設計和開發控制，製造商應選擇其認為最合適的一種。

3. C級：建立和維護完整的質量管理體系

4. D級：建立和維護完整的質量管理體系

注意事項：

1. 由第三方代表製造商實施的質量管理體系應由製造商負責，並受製造商質量管理體系的控制。

2. 泰國接受的質量管理體系（QMS）標準包括：

． MDA 註冊 CAB 頒發的 QMS 證書

．由法規(NANDO)指定機構頒發的 QMS 證書

．認可國家（美國、加拿大、澳大利亞、日本、歐盟）的認證機構出具的QMS證書，由 CAB決定接受或不接受來自其他國家的認證機構的 QMS 認證的決定，。

網頁：https://portal.mda.gov.my/doc-list/guidance-document.html

Good Distribution Practice for Medical Devices (GDPMD): Medical devices intended for sale in Malaysia must comply with GDPMD and be verified by a designated certification body (CAB). needed file:

1. Business profile, activities/operations, compliance with medical device regulatory requirements and business obligations including those outsourced processes or activities/operations

2. Scope of the GDPMD regulatory compliance system, including details and reasons for any exclusions and/or non-applicability

3. Medical devices and their compliance status

4. System Requirements Procedures and References

5. Documents required by the enterprise to ensure the effective planning, operation and control of the compliance process

6. Records of regulatory compliance system requirements

7. Conformity assessment and registration of venues, personnel, and medical devices

8. A detailed description of how each medical device designated within the scope of the GDPMD regulatory compliance system satisfies relevant and applicable regulatory requirements

9. For each type of medical device it handles, the establishment shall establish and maintain documentation containing definitions

．Product Specifications & Installation

． Complete distribution process and installation services.

10. The records of the GDPMD Regulatory Compliance System must be legible, easily identifiable, and retrievable

11. Records need to be kept for a period of time

． According to relevant regulations

． At least equal to the service life of the medical device product or not less than two years from the date of the medical device listing

Quality Management System (QMS):Manufacturers of medical devices that sell in Thailand should be ISO 13485 certified,

1. Class A: Complete quality management system or no design and development control, the manufacturer should choose the one that it deems most suitable.

2. Class B: Complete quality management system or no design and development control, the manufacturer should choose the one that he deems most suitable.

3. Grade C: Establish and maintain a complete quality management system

4. Level D: Establish and maintain a complete quality management system

Notes

1. The quality management system implemented by a third party on behalf of the manufacturer shall be the responsibility of the manufacturer and controlled by the manufacturer’s quality management system.

2. The quality management system (QMS) standards accepted in Thailand include:

．QMS certificate issued by MDA registration CAB

．QMS certificate issued by a regulatory (NANDO) designated body

．The QMS certificate issued by the certification body of the recognized country (United States, Canada, Australia, Japan, the European Union), the decision of the CAB to accept or not to accept the QMS certification from the certification body of other countries,.

【參考連結】

https://portal.mda.gov.my/doc-list/guidance-document.html

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口醫療器材後，如果委託馬來西亞的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

After a foreign subsidiary imports medical devices and entrusts a distributor in Malaysia to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

需要由馬來西亞當地居民或於馬來西亞有永久住址/領有工作簽證之企業負責人申請經銷許可證。

A distribution permit needs to be applied for by a local resident of Malaysia or the person in charge of a business with a permanent address/work visa in Malaysia.

Manufacturers, Authorized Representatives (AR) should establish a Post-market Surveillance System (PMS) to track sales records, customer opinion records, and be responsible for reporting adverse reactions. of any incident involving its medical equipment.
For medical equipment registered in Malaysia, businesses should investigate the cause of the accident and make on-site corrections, taking action if necessary to prevent the incident from recurring to ensure safety and performance of the medical equipment.

【參考連結】

https://portal.mda.gov.my/industry/establishment-licence/how-to-apply-for-establishment-licence.html

HLF-TW-85

各國醫療器材登記法規問答集

接洽我們：
Email：kul4ww@evershinecpa.com
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