马来西亚医疗器材登记法规问题集
Email：kul4ww@evershinecpa.com
或
马来西亚永辉BPO有限公司
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CA Aaron Yap, 马来西亚籍说马来西亚文中文和英文
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skype: annylin8008
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HLF-TW-10
请问马来西亚对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？
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：
医疗器材管理局 (MDA) 是马来西亚卫生部辖下的法定机构，旨在管理、规范医疗器材、其行业和活动。
医疗器材是指：
1. 製造商打算单独或组合用于人类的任何仪器、装置、器具、机器、器具、植入物、体外试剂或校准器、软件、材料或其他类似、相关物品目的。
2. 疾病的诊断、预防、监测、治疗或缓解。
3. 损伤的诊断、监测、治疗、减轻或补偿。
4. 解剖或生理过程的调查、替换或修改或支持。
5. 支持或维持生命。
6. 控制受孕。
7. 医疗器材消毒。
8. 通过对人体进行体外检查，为医疗或诊断目的提供信息。
MDA规定製造商应对医疗器材进行适当分类，且当一项医疗器材适用多项等级时，则以最高等级为标准。
根据MDA提供的分类准则，可先将医疗器材分为非侵入性医疗器材、侵入性医疗器材、主动式医疗器材等项目，再依使用方式进行分类。另外，当企业或指定验证机构（CAB）对医疗器材产品分类有所争议时，企业可于争议发生后的30日内通知MDA相关情形，MDA最晚则须于收到通知后的30日内告知企业其对该医疗器材分类的最终决定。
一般医疗器材与体外诊断医疗器材，依风险等级由低到高分为A、B、C、D。设备必须通过合格评定机构 (CAB) 对 B、C 和 D 类设备的製造商文档进行简要技术审查。ISO证书、CE证书等文件必须提交给CAB。
审核通过后，CAB将颁发证书。设备註册的最终包括通用提交档案模板 (CSDT)、CAB 证书和申请，必须以电子方式提交给 MDA 以供审查和批准。
1. A级：风险等级低
．须向泰国 FDA 申请製造或销售许可。
．泰国政府机构得在必要情况下针对此分类的医疗器材进行测试与查验。
．一般医疗器材：简易手术器材、压舌板、玻璃液体温度计、检查灯、简易伤口敷料、氧气面罩、听诊器、助行器等。
．体外诊断医疗器材：临床化学分析仪，製备的选择性培养基等。
2. B级：风险等级中低
．需向泰国 FDA 进行申报（提供产品规格资料、生产过程等）取得产品通知（product notification）后才能生产。
．一般医疗器材：皮下注射针头、吸引设备、麻醉呼吸迴路、吸引器、外部骨骼生长模拟器、助听器、水凝胶敷料、患者自控止痛、光疗装置、X 射线胶片等。
．体外诊断医疗器材：维生素B12，妊娠自检，抗核抗体，尿液试纸等。
3. C级：风险等级中高
．需向泰国 FDA 进行申报（提供产品规格资料、生产过程等）取得产品通知（product notification）后才能生产。
．一般医疗器材：肺呼吸机、骨科植入物、婴儿保温箱、血氧器、血袋、隐形眼镜消毒/清洁产品、深部伤口敷料、除颤器、放射治疗设备、呼吸机等。
．体外诊断医疗器材：血糖自测，HLA 分型。PSA 筛查，风疹等。
4. D级：风险等级高
．生产或进口前需要向泰国 FDA 完整地註册与申请产品许可。
．此类别的医疗器材均须通过泰国FDA的验证。
．一般医疗器材：起搏器及其导线、植入式除颤器、植入式输液泵、心脏瓣膜、宫内节育器、神经导管、血管假体、支架等。
．体外诊断医疗器材：HIV献血者筛查，HIV血液诊断等。
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.
【参考连结】
https://portal.mda.gov.my/doc-list/legislation.html
HLF-TW-20
外国公司要到马来西亚销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
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：
需要由马来西亚当地居民或于马来西亚有永久住址/领有工作签证之企业负责人申请经销许可证。
经销商申请许可证须符合医疗器材优良经销规范（GDPMD），再交相关资料交由指定验证机构（CAB）进行验证。
CAB核发相关证明与报告确认经销商符合资格要求后，该经销商可透过MeDC@St系统申请经销许可证。
许可证有效期限为自核发日起算三年，且最晚须于到期一年前申请再核发。
具备条件
1. 申请人为企业负责人：须为高阶管理阶级，且为马来西亚居民，或于马来西亚有永久住址或领有工作签证之人。
2. 联络人：负责许可证申请程序相关联络。
3. 获得验证机构（CAB）品质管理认证，确认产品符合GDPMD的要求。
4. 非製造商或授权代理商之经销者，须取得製造商或授权代理商之授权许可。
申请内容
1. 企业详情
．企业类型：製造商/ 授权代理商/分销商/进口商
．商业登记：商业登记编号
．机构名称：详细信息、联繫方式
2. 负责人
．马来西亚公民身份证
．非马来西亚人须有护照、机构负责人签署的负责人任命书/就业证
．联繫人(如果与负责人不同，须提供详细联繫方式)
．质量管理体系（QMS）：如果QMS已註册 CAB 认证，须註明製造商的 QMS ISO/ ISO 13485 或其他机构类型的 GDPMD，并提供 CAB 的名称和註册号。
3. 设立许可申请的证明
．下载设立许可证明书
．由负责人填写、盖章并签署表格后打印在公司信笺上
．上传填妥的证明表格
4. 申请提交
．预览后提交申请表
5.申请表内容
．一般性资讯
．製造商资讯
．产品群组分类
．共同技术文件（Common Submission Dossier Template, CSDT）及补充文件
．上市后市场监督纪录
．符合性声明书
．产品登记认证
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
【参考连结】
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
外国公司要到马来西亚销售医疗器材，可以指派马来西亚公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
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：
外国製造的医疗器材需由马来西亚本地的授权代理商（Authorised Representative, AR）协助申请医疗器材登记、处理医疗器材产品进口、经销等事宜。
授权代理商在申请许可证时，须先符合医疗器材优良经销规范（Good Distribution Practice for Medical Devices, GDPMD），再交相关资料交由指定验证机构（CAB）进行验证。
在CAB核发相关证明与报告确认授权代理商之资格符合要求后，授权代理商可透过MeDC@St系统申请许可证。
许可证有效期限为自核发日起算三年，且最晚须于到期一年前申请再核发。
具备资料
1.申请人为企业负责人：须为高阶管理阶级，且为马来西亚居民，或于马来西亚有永久住址或领有工作签证之人。
2.联络人：负责许可证申请程序相关联络。
3.获得验证机构（CAB）品质管理认证，确认产品符合GDPMD要求。
4.製造商的授权许可。
申请内容
1. 企业详情
．企业类型：製造商/ 授权代理商/分销商/进口商
．商业登记：商业登记编号
．机构名称：详细信息、联繫方式
2. 负责人
．马来西亚公民身份证
．非马来西亚人须有护照、机构负责人签署的负责人任命书/就业证
．联繫人(如果与负责人不同，须提供详细联繫方式)
．质量管理体系（QMS）：製造商的 QMS ISO/ ISO 13485 或其他机构类型的 GDPMD，并提供 CAB 的名称和註册号。
3. 设立许可申请的证明
．下载设立许可证明书
．由负责人填写、盖章并签署表格后打印在公司信笺上
．上传填妥的证明表格
4. 申请提交
．预览后提交申请表
5.申请表内容
．一般性资讯
．製造商资讯
．产品群组分类
．共同技术文件（Common Submission Dossier Template, CSDT）及补充文件
．上市后市场监督纪录
．符合性声明书
．产品登记认证
製造商、授权代表(AR)应建立上市后监督系统(Post-market Surveillance System, PMS)追踪销售纪录、客户意见纪录、负责不良反应通报等，每家机构都应向当局报告在马来西亚境内外发生的涉及其医疗器材的任何事件。
马来西亚註册的医疗器材，企业应调查事故原因并进行现场纠正，必要时採取行动，以防止事件再次发生，以确保安全和医疗器材性能。
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.
【参考连结】
https://portal.mda.gov.my/medc-st.html
https://portal.mda.gov.my/doc-list/guidance-document.html
HLF-TW-35
HLF-TW-40
外国公司销售到马来西亚医疗器材本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了马来文外，其他哪种语文也可以？网页？
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：
外国製造的医疗器材需由马来西亚本地的授权代理商（Authorised Representative, AR）协助申请医疗器材登记、处理医疗器材产品进口、经销等事宜。
授权代理商在申请许可证时，须先符合医疗器材优良经销规范（Good Distribution Practice for Medical Devices, GDPMD），再交相关资料交由指定验证机构（CAB）进行验证。
在CAB核发相关证明与报告确认授权代理商之资格符合要求后，授权代理商可透过MeDC@St系统申请许可证。
许可证有效期限为自核发日起算三年，且最晚须于到期一年前申请再核发。
具备资料
1.申请人为企业负责人：须为高阶管理阶级，且为马来西亚居民，或于马来西亚有永久住址或领有工作签证之人。
2.联络人：负责许可证申请程序相关联络。
3.获得验证机构（CAB）品质管理认证，确认产品符合GDPMD要求。
4.製造商的授权许可。
申请内容
1. 企业详情
．企业类型：製造商/ 授权代理商/分销商/进口商
．商业登记：商业登记编号
．机构名称：详细信息、联繫方式
2. 负责人
．马来西亚公民身份证
．非马来西亚人须有护照、机构负责人签署的负责人任命书/就业证
．联繫人(如果与负责人不同，须提供详细联繫方式)
．质量管理体系（QMS）：製造商的 QMS ISO/ ISO 13485 或其他机构类型的 GDPMD，并提供 CAB 的名称和註册号。
3. 设立许可申请的证明
．下载设立许可证明书
．由负责人填写、盖章并签署表格后打印在公司信笺上
．上传填妥的证明表格
4. 申请提交
．预览后提交申请表
5.申请表内容
．一般性资讯
．製造商资讯
．产品群组分类
．共同技术文件（Common Submission Dossier Template, CSDT）及补充文件
．上市后市场监督纪录
．符合性声明书
．产品登记认证
註册医疗器材应标有马来西亚医疗器材註册号，并应在医疗器材註册之日起 6 个月内进行。
鼓励使用註册证上的二维码标示医疗器材註册号。
允许的格式示例：
1. MDA註册。编号 xxxxxxx
2. 在 MDA GXXXXX 註册
3. 註册号 Gxxxxxxx
4. Gxxxxxxx马来西亚註册。
5. 编号 XXXXXXX
6. 医疗器材註册号 XXXXXXX
7. MDA GXXXXX
注意事项：
1. 医疗器材的标籤应清晰、永久且显眼。
2. 标籤的媒介、格式、内容、可读性和位置应适合特定设备、其预期目的以及预期用户的技术知识、经验、教育或培训。
3. 所有家用设备应随附纸本标籤。
4. 风险分析中确定的任何残馀风险应在标籤中反映为禁忌症或警告。
5. 标籤可以通过多种媒体和多种方式提供给用户，例如印刷文件、设备中的显示屏、製造商的网站以及磁性或光学媒体。无论採用何种媒体或手段，信息都应针对预期的用户群体。
6. 符合医疗器材法和法规的标籤可以在进口或製造后进行，但要在投放市场之前进行。标识内容应当按照医疗器材註册时报送主管部门的规定执行。批号、批号或序列号、生产日期和有效期不得过度标註。
标籤位置
1. 在可行和适当的情况下，应在医疗器材本身和/或每个单元的包装（初级包装）上提供识别和安全使用医疗器材所需的资讯，和/或多种医疗器材的包装（二级包装）。如果这样做不可行或不合适，则可在随附的传单、手册、包装插页等中列出资讯。
2. 医疗器材註册号、製造商/授权代表详细信息和二维码（如果有）应位于客户/用户在销售点可以看到的位置。
3. 对于因医疗器材单独包装不实用而被包装在一起的医疗器材，标籤应作为单张或多张随附传单、包装插页、文件或其他介质提供
4. 如果向单个用户和/或地点提供多个医疗器材或一起包装，则可以仅提供一份标籤副本，但应根据要求提供更多副本。
5. 对于标籤上提供的资讯，应在标籤上提供马来西亚语翻译。
格式
1. 标籤格式应符合适用的医疗器材标籤国际标准。
2. 鼓励使用国际公认的符号，前提是医疗器材安全不会因患者或用户缺乏理解而受到影响。
语言
1. 家用医疗器材必须使用马来西亚语。
2. 其他类型的医疗器材标籤应使用英文。
3. 必要时可使用其他语言。
4.应提供马来西亚语翻译。
标籤内容
1.使用户能够识别的医疗器材的详细信息，包括器材名称（品牌名称、通用名称和指定名称）、型号和标识号
2.批号/批号（例如一次性使用的医疗器材或试剂）或序列号（例如电动医疗器材）的指示，以利採取适当的行动追踪和召回医疗器材设备。
3.明确指示医疗器材可以安全使用的日期，至少以年和月表示，根据医疗器材的类型，註明製造日期。
4.必要时，首次打开主容器后的储存条件和保质期，以及工作溶液的储存条件和稳定性。
5.製造商和授权代理商（如果是外国製造商）的名称、地址和联繫方式 (电子邮件和/或电话号码和/或网站地址)，以获得技术上的援助。
6.有关医疗器材的技术细节，例如：器材规格/配方、颜色、尺寸、兼容性等。
7.医疗器材的描述和预期用途。
8.医疗器材使用说明。
9.对安全使用医疗器材的任何不良副作用、限制、警告和/或预防措施。
10.医疗器材的任何必要的上市后服务需求。
11.如果适用并基于风险评估需附上处置信息（例如：感染或微生物危害、环境危害；物理危害）。
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
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).
【参考连结】
https://portal.mda.gov.my/doc-list/guidance-document.html
https://portal.mda.gov.my/medc-st.html
HLF-TW-45
HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了马来文外，其他哪种语文也可以？网页？
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：
外国製造的医疗器材需由马来西亚本地的授权代理商（Authorised Representative, AR）协助申请医疗器材登记、处理医疗器材产品进口、经销等事宜。
授权代理商在申请许可证时，须先符合医疗器材优良经销规范（Good Distribution Practice for Medical Devices, GDPMD），再交相关资料交由指定验证机构（CAB）进行验证。
在CAB核发相关证明与报告确认授权代理商之资格符合要求后，授权代理商可透过MeDC@St系统申请许可证。
许可证有效期限为自核发日起算三年，且最晚须于到期一年前申请再核发。
具备资料
1.申请人为企业负责人：须为高阶管理阶级，且为马来西亚居民，或于马来西亚有永久住址或领有工作签证之人。
2.联络人：负责许可证申请程序相关联络。
3.获得验证机构（CAB）品质管理认证，确认产品符合GDPMD要求。
4.製造商的授权许可。
申请内容
1. 企业详情
．企业类型：製造商/ 授权代理商/分销商/进口商
．商业登记：商业登记编号
．机构名称：详细信息、联繫方式
2. 负责人
．马来西亚公民身份证
．非马来西亚人须有护照、机构负责人签署的负责人任命书/就业证
．联繫人(如果与负责人不同，须提供详细联繫方式)
．质量管理体系（QMS）：製造商的 QMS ISO/ ISO 13485 或其他机构类型的 GDPMD，并提供 CAB 的名称和註册号。
3. 设立许可申请的证明
．下载设立许可证明书
．由负责人填写、盖章并签署表格后打印在公司信笺上
．上传填妥的证明表格
4. 申请提交
．预览后提交申请表
5.申请表内容
．一般性资讯
．製造商资讯
．产品群组分类
．共同技术文件（Common Submission Dossier Template, CSDT）及补充文件
．上市后市场监督纪录
．符合性声明书
．产品登记认证
註册医疗器材应标有马来西亚医疗器材註册号，并应在医疗器材註册之日起 6 个月内进行。
鼓励使用註册证上的二维码标示医疗器材註册号。
允许的格式示例：
1. MDA註册。编号 xxxxxxx
2. 在 MDA GXXXXX 註册
3. 註册号 Gxxxxxxx
4. Gxxxxxxx马来西亚註册。
5. 编号 XXXXXXX
6. 医疗器材註册号 XXXXXXX
7. MDA GXXXXX
注意事项：
1. 医疗器材的标籤应清晰、永久且显眼。
2. 标籤的媒介、格式、内容、可读性和位置应适合特定设备、其预期目的以及预期用户的技术知识、经验、教育或培训。
3. 所有家用设备应随附纸本标籤。
4. 风险分析中确定的任何残馀风险应在标籤中反映为禁忌症或警告。
5. 标籤可以通过多种媒体和多种方式提供给用户，例如印刷文件、设备中的显示屏、製造商的网站以及磁性或光学媒体。无论採用何种媒体或手段，信息都应针对预期的用户群体。
6. 符合医疗器材法和法规的标籤可以在进口或製造后进行，但要在投放市场之前进行。标识内容应当按照医疗器材註册时报送主管部门的规定执行。批号、批号或序列号、生产日期和有效期不得过度标註。
标籤位置
1. 在可行和适当的情况下，应在医疗器材本身和/或每个单元的包装（初级包装）上提供识别和安全使用医疗器材所需的资讯，和/或多种医疗器材的包装（二级包装）。如果这样做不可行或不合适，则可在随附的传单、手册、包装插页等中列出资讯。
2. 医疗器材註册号、製造商/授权代表详细信息和二维码（如果有）应位于客户/用户在销售点可以看到的位置。
3. 对于因医疗器材单独包装不实用而被包装在一起的医疗器材，标籤应作为单张或多张随附传单、包装插页、文件或其他介质提供
4. 如果向单个用户和/或地点提供多个医疗器材或一起包装，则可以仅提供一份标籤副本，但应根据要求提供更多副本。
5. 对于标籤上提供的资讯，应在标籤上提供马来西亚语翻译。
格式
1. 标籤格式应符合适用的医疗器材标籤国际标准。
2. 鼓励使用国际公认的符号，前提是医疗器材安全不会因患者或用户缺乏理解而受到影响。
语言
1. 家用医疗器材必须使用马来西亚语。
2. 其他类型的医疗器材标籤应使用英文。
3. 必要时可使用其他语言。
4.应提供马来西亚语翻译。
标籤内容
1.使用户能够识别的医疗器材的详细信息，包括器材名称（品牌名称、通用名称和指定名称）、型号和标识号
2.批号/批号（例如一次性使用的医疗器材或试剂）或序列号（例如电动医疗器材）的指示，以利採取适当的行动追踪和召回医疗器材设备。
3.明确指示医疗器材可以安全使用的日期，至少以年和月表示，根据医疗器材的类型，註明製造日期。
4.必要时，首次打开主容器后的储存条件和保质期，以及工作溶液的储存条件和稳定性。
5.製造商和授权代理商（如果是外国製造商）的名称、地址和联繫方式 (电子邮件和/或电话号码和/或网站地址)，以获得技术上的援助。
6.有关医疗器材的技术细节，例如：器材规格/配方、颜色、尺寸、兼容性等。
7.医疗器材的描述和预期用途。
8.医疗器材使用说明。
9.对安全使用医疗器材的任何不良副作用、限制、警告和/或预防措施。
10.医疗器材的任何必要的上市后服务需求。
11.如果适用并基于风险评估需附上处置信息（例如：感染或微生物危害、环境危害；物理危害）。
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 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
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).
【参考连结】
https://portal.mda.gov.my/doc-list/guidance-document.html
https://portal.mda.gov.my/medc-st.html
HLF-TW-55
HLF-TW-60
经过核准登记的医疗器材，进口到马来西亚要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
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：
要将货物进口到马来西亚，需要向马来西亚皇家海关署（JKDM）申报、缴纳关税/税款的进口税、消费税、销售税。
1.海关申报：所有进口到马来西亚的货物必须通过以下方式择一申报
．指定报关员
．自我声明(AEO 计划 – AEO 门户)
．直接用户
2. 商品分类：进口商需要获得对要进口到马来西亚的商品的确认通过获取货物的正确关税代码是否需要缴纳任何关税/税款。
3. 检查物品是否为受控商品或进口违禁品：
．检查拟进口的货物是否为管制货物或受当局禁止或限制进口的货物。
．确认进口之前获得许可/批准。
4. 申报和准备海关放行文件：每个进口商应在货物抵达或抵达马来西亚时，亲自或由其代理人对进口货物进行完整和真实的申报。
．电子报关单
．提交进口许可证(电子档案或副本)
．提单/空运单
．发票(採购订单或信用证)
．装箱单
．原产国证明
．其他相关文件(检验证书、分析证书、成分证书、清真证书、产品规格证书等)
5. 货物检验：JKDM保留检查货物以确保进口符合法律法规的权利。
6. 缴纳关税/税款进口：货物的应付关税/税款必须由进口商在货物到达时支付。可以通过柜檯或电子支付。
7. 海关批准
8. 海关放行
9. 保存文档：进口记录在马来西亚保存七年
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
【参考连结】
http://www.customs.gov.my/en/pages/main.aspx
HLF-TW-70
马来西亚医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
医疗器材优良经销规范（Good Distribution Practice for Medical Devices, GDPMD）：欲在马来西亚销售的医疗器材皆需符合GDPMD，并由指定验证机构（CAB）进行验证。所需文件：
1. 企业的概况、活动/运营、对医疗器材监管要求的遵守情况以及企业的义务，包括那些外包流程或活动/运营
2. GDPMD 监管合规系统的范围，包括任何排除和/或不适用的细节和理由
3.医疗器材及其合规状况
4.系统要求的程序及其参考
5. 企业为确保合规流程的有效规划、操作和控制所需的文件
6. 监管合规系统要求的记录
7. 活动场所、人员、医疗器材合格评定和註册
8. 对 GDPMD 监管合规体系范围内指定的每种医疗器材如何满足相关和适用监管要求的详细描述
9. 对于其处理的每种类型的医疗器材，企业应建立并维护文件，其中包含定义
． 产品规格和安装
． 完整的分发过程以及安装服务。
10. GDPMD 监管合规系统的记录必须清晰易读、易于识别和检索
11.记录需要保留一段时间
．依据相关法规要求
．至少相当于医疗器材产品的使用寿命或自医疗器材上市之日起不少于两年
质量管理体系（QMS）
于泰国贩售的医疗器材製造商应通过 ISO 13485 认证，
1. A级：完整的质量管理体系或无设计和开发控制，製造商应选择其认为最合适的一种。
2. B级： 完整的质量管理体系或无设计和开发控制，製造商应选择其认为最合适的一种。
3. C级：建立和维护完整的质量管理体系
4. D级：建立和维护完整的质量管理体系
注意事项：
1. 由第三方代表製造商实施的质量管理体系应由製造商负责，并受製造商质量管理体系的控制。
2. 泰国接受的质量管理体系（QMS）标准包括：
． MDA 註册 CAB 颁发的 QMS 证书
．由法规(NANDO)指定机构颁发的 QMS 证书
．认可国家（美国、加拿大、澳大利亚、日本、欧盟）的认证机构出具的QMS证书，由 CAB决定接受或不接受来自其他国家的认证机构的 QMS 认证的决定，。
网页：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,.
【参考连结】
https://portal.mda.gov.my/doc-list/guidance-document.html
https://portal.mda.gov.my/doc-list/guidance-document.html
HLF-TW-75
HLF-TW-77
HLF-TW-80
外国子公司进口医疗器材后，如果委託马来西亚的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？
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：
需要由马来西亚当地居民或于马来西亚有永久住址/领有工作签证之企业负责人申请经销许可证。
製造商、授权代表(AR)应建立上市后监督系统(Post-market Surveillance System, PMS)追踪销售纪录、客户意见纪录、负责不良反应通报等，每家机构都应向当局报告在马来西亚境内外发生的涉及其医疗器材的任何事件。
马来西亚註册的医疗器材，企业应调查事故原因并进行现场纠正，必要时採取行动，以防止事件再次发生，以确保安全和医疗器材性能。
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.
【参考连结】
https://portal.mda.gov.my/industry/establishment-licence/how-to-apply-for-establishment-licence.html
HLF-TW-85
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