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CFS vs EC certificate for medical device import in Thailand
CFS vs EC certificate for medical devices: what each one proves
The CFS vs EC certificate question comes up whenever a European device is imported into Thailand. A Certificate of Free Sale (CFS) is issued or endorsed by a government body in the country of manufacture and confirms that the product may be sold there. An EC certificate is issued to the manufacturer by a European Notified Body after it has assessed the product or the quality system under EU medical device law. One proves market status; the other proves an independent assessment.
Importers often ask whether an EC certificate can stand in for a missing CFS. The honest answer is that it depends on which slot in the Thai application you are trying to fill. Since the Medical Device Act (No. 2) B.E. 2562 (2019), Thai control is split into three levels: licence, detailed listing and notification. Each level has its own document list in a 2020 Ministerial Regulation, and none of those lists uses the words Certificate of Free Sale.
This guide explains what each certificate is, what the Thai submission actually asks for, where an EC certificate helps and where neither document can substitute for the other. For the full import route, from risk class to the port checkpoint, see importing medical devices into Thailand. For CFS basics such as who issues one and what it must state, see what a Certificate of Free Sale is.
EC certificate vs Declaration of Conformity
European suppliers usually send two kinds of paper, and they carry very different weight.
EC certificate (from a Notified Body)
Issued by a conformity assessment body designated in the EU after reviewing the technical file or quality system. It names the manufacturer, the product scope and an expiry date. The 2024 Thai FDA notification on documents that need not be submitted lists European Union Notified Bodies (EU NB) as one of the foreign authorities whose approval supports a concise evaluation.
Declaration of Conformity (DoC)
Signed by the manufacturer or product owner itself, stating that the product meets the listed requirements and standards. Nobody outside the company checks it. The Medical Device Control Division guidance on DoCs recommends the version that cites Thai medical device law, and allows a version citing the ASEAN Medical Device Directive (AMDD) where the owner wants one document for several ASEAN markets. The guidance also says a DoC is not evidence that a Thai permission has been granted.
Certificate of Free Sale
Issued or endorsed by the authority of the producing country to confirm the product is on sale there. It says nothing about technical testing and nothing about Thai requirements.
In short: the EC certificate is an external assessment, the DoC is the manufacturer's own declaration, and the CFS is evidence of market status. They are not interchangeable even when a supplier sends them as one bundle.
Documents for medical device import: what the 2020 Ministerial Regulations ask for
The real document lists sit in three Ministerial Regulations from 2020, one per control level. Confirm your level first, then ask the manufacturer for documents that match it.
Notification (lowest risk)
Clause 2 of the 2020 Ministerial Regulation on notification asks for the establishment registration number, product details and label, manufacturing or product-owner information, the foreign registration history where one exists, sterility or testing and calibration evidence where relevant, a declaration of conformity from the manufacturer, and a letter of authorisation from the product owner for imports.
Detailed listing and licence
Clause 2 of the 2020 Ministerial Regulation on licences lists 14 items, and the regulation on detailed listing uses the same headings. The items relevant here are:
- (8) quality system certificate
- (9) the manufacturer's statement on intended use, indications, packaging, label and instructions
- (10) the manufacturer's declaration of conformity
- (11) the manufacturer's statement of marketing history
- (12) the manufacturer's safety statement
- (13) evidence of approval from a foreign medical device regulator recognised by the Thai FDA
- (14) a letter of authorisation from the product owner, for imports
Item (11) is a statement from the manufacturer or product owner, not a government certificate. The Thai FDA IVD registration guide calls it the Marketing History Declaration and says the five manufacturer documents (Declaration of Conformity, Letter of Authorization, Declaration Letter, Marketing History Declaration and Safety Declaration) do not need endorsement by a government body or a notary public.
Source: Ministerial Regulations on medical device licences and notification B.E. 2563 · Thai FDA notification B.E. 2567 on documents not required · Division IVD guide and DoC guidance
Full vs concise evaluation: where an EC certificate counts most
The 2024 Thai FDA notification on documents that need not be submitted splits the review of licence and detailed-listing applications into two routes.
Full evaluation
The applicant does not submit items (9), (11), (12) and (13), because reviewers assess the whole CSDT technical file.
Concise evaluation
The applicant does not submit the design verification and validation summary, the risk analysis, or the disposal method document (with some exceptions), but every condition below must be met:
- The device is approved or registered by at least one of: the Therapeutic Goods Administration (Australia), Health Canada, European Union Notified Bodies, the Japanese Ministry of Health, Labour and Welfare, the US Food and Drug Administration, or WHO Prequalification of In Vitro Diagnostics.
- That foreign approval has been held for at least one year.
- Trade name, intended use, indications, labelling, instructions for use and packaging are the same as approved.
- Devices covered by a product-specific MOPH notification are excluded.
This is where an EC certificate counts most, because it comes straight from a listed authority. A CFS from a country outside the list does not open the concise route, even though a government issued it. Reviewers may still ask for any exempted document if they have doubts about quality, performance or safety.
Can a CFS and an EC certificate replace each other?
Only when the document you file answers what the slot asks. Case by case:
Where an EC certificate works well
Item (13), evidence of foreign approval, and the concise-evaluation condition, which names EU Notified Bodies. Check that the models, trade name and intended use on the certificate match the Thai application and that it has not expired.
Where one cannot substitute for the other
- Declaration of conformity, item (10), or item (7) for notification. This is the manufacturer's declaration against Thai requirements. Division guidance points to the Thai-law or AMDD format, so an EU DoC citing European law, or an EC certificate, is not the requested document.
- Marketing history, item (11). A manufacturer's statement on the Division's form. A CFS may support it, but prepare the manufacturer's statement as well.
- Quality system certificate, item (8). Must name the manufacturer, the site and a scope covering the product. Neither a CFS nor a DoC does this job.
- Letter of authorisation, item (14). Nothing replaces it. See letter of authorization for the Thai FDA.
The 2007 rule importers still hear about
A Thai FDA regulation of B.E. 2550 (2007) on certificates for importing medical devices served the former import-certificate system. It required a free-sale certificate from the producing country's authority, and allowed CE-marked products to use an EC certificate or EC Declaration of Conformity under stated conditions. That is the origin of the belief that an EC certificate always replaces a CFS. The 2020 MOPH notifications on device groups requiring notification or a licence told holders of old import certificates to file under the new system before their certificates expired, so new applications should follow the 2020 Ministerial Regulations. Confirm with the Medical Device Control Division before relying on the 2007 rule.
Validity, language and matching names across foreign documents
Foreign documents are more often returned for small details than for being the wrong type. Division guidance points to these checks:
- Still valid. The non-IVD document preparation guidance says certificates must be valid; if one expires before the Thai certificate is issued, a new one is needed. A Notified Body certificate should have enough life left for the time the file is in the system.
- Same names everywhere. The Full-CSDT checklist for general non-IVD devices requires the English name to match across the label, IFU, product list, DoC and letter of authorisation. If the EC certificate uses a broad product-group name, attach a model list that links to the Thai application.
- Same manufacturer and site. The Full CSDT manual requires the quality system certificate to match the manufacturer, the site and the scope.
- Language. The IVD checklist expects documents from the owner or manufacturer in English. Products for home use need a Thai label and Thai instructions.
- Intended use as approved. On the concise route, the Thai label must not add indications missing from the foreign approval.
Manufacturer statements on the Division's forms, such as the Marketing History Declaration and Safety Declaration, need no notarisation under the IVD guide, but they must be signed by an authorised person and contain real information. A blank form does not confirm that no adverse events occurred.
Thailand IVD grouping requirements
An importer with many models or test kits does not always have to file them one by one. The Thai FDA notification on medical device grouping sets six grouping types, and the applicant may choose single or grouped filing.
- SINGLE: one item.
- SYSTEM: one product owner; components work together for one purpose.
- FAMILY: same risk class and intended purpose; very similar design and manufacturing.
- SET: two or more devices packed together for one purpose, classed at the highest risk among them; items sold separately need single filing.
- IVD TEST KIT: reagents and materials used together, without the analyser.
- IVD CLUSTER: conditions on manufacturer, risk class and test method set out in the annex.
The Division's updated IVD grouping manual adds that the general IVD cluster rule covers Class 1 or Class 2 products with the same test method and category, that IHC and FISH probes follow their own framework, and that a family must share risk, purpose and design. Being one brand is not enough.
For documents, this means the EC certificate or other foreign evidence must cover every item in the group. If a certificate covers only some models, split the application or complete the evidence before grouping.
How to register a medical device in Thailand and the licence to distribute
Overseas manufacturers often ask how to register a medical device in Thailand and whether a licence to distribute is needed. The legal sequence is:
- Register the import establishment. The Medical Device Act requires anyone who manufactures or imports devices to register an establishment first. The filer is therefore a Thai company or person with import and storage premises; a foreign manufacturer files through the importer it authorises.
- File each product at its control level: notification, detailed listing or licence, with the documents in the 2020 Ministerial Regulations.
- Sell only after the product certificate is issued. The Medical Device Act (No. 2) B.E. 2562 prohibits selling devices without a licence, listing receipt or notification receipt.
- Sales licence for designated groups. Section 6 (3) lets the Minister designate devices whose sellers must hold a licence, and the 2012 Ministerial Regulation on sales licences requires maps and plans of the sales and storage premises. Distributors should check whether their products fall in such a group.
- Quality system for import and sale. The 2023 MOPH notification on quality systems for importing or selling devices requires control of receiving, storage and delivery, with records that allow tracing along the supply chain.
A CFS or EC certificate is only part of step 2. It does not let anyone skip establishment registration or the sales licence question.
Checklist before asking the manufacturer for documents
Use this list before sending a document request to an overseas manufacturer, so you do not have to ask several times.
- Confirm the control level first; the document lists differ.
- Ask whether the product holds approval from an authority on the 2024 list, and for how long, to choose between full and concise evaluation.
- Request the EC certificate with its model list, and check the model names against the label and the Thai application.
- Request a DoC in the Thai-law or AMDD format, not only the EU DoC.
- Request the manufacturer statements on the Division's forms, such as marketing history and safety, where the route needs them.
- Request a quality system certificate whose scope covers the product and site.
- Keep the CFS as supporting evidence, especially when it shows sales in the home market.
- Check every expiry date against your filing plan.
You can check expiry dates, signatures and manufacturer names across documents with the import document checker. To have our consultants assemble and file the dossier, see import services, or search the full notifications in our archive.
- ✓Know the control levelNotification, detailed listing or licence
- ✓Choose full or concise evaluationConcise needs approval from a listed authority held for at least one year
- ✓EC certificate with model listModel names match the label and Thai application
- ✓DoC in Thai-law or AMDD formatThe EU DoC alone is not enough
- ✓Manufacturer statements on Division formsMarketing history and safety, where the route needs them
- ✓Check every expiry dateA certificate that lapses during review must be replaced
Source: Ministerial Regulations B.E. 2563 · Thai FDA notification B.E. 2567 · non-IVD document preparation guidance
Frequently asked questions
Our European manufacturer has an EC certificate but no CFS. Can we still import?
It depends on the slot. For evidence of foreign approval and for the concise evaluation route, an EC certificate from a Notified Body fits best. The declaration of conformity and the marketing history statement are manufacturer documents on the Division's forms and must be prepared separately.
Can the EU Declaration of Conformity be used as the DoC in a Thai application?
Division guidance recommends a DoC citing Thai medical device law, or the AMDD format where conditions are met. Ask the manufacturer for that format and keep the EU DoC as supporting material.
Which foreign approvals qualify for concise evaluation?
Under the 2024 Thai FDA notification: TGA, Health Canada, EU Notified Bodies, Japan's MHLW, the US Food and Drug Administration or WHO PQ IVD, held for at least one year, with the same trade name, intended use, labelling and packaging as approved.
Do manufacturer declarations need notarisation?
The Thai FDA IVD registration guide states that the five manufacturer documents, including the DoC, Marketing History Declaration and Safety Declaration, do not need endorsement by a government body or notary public. They must be signed by an authorised person and match the application.
Is a separate licence needed to distribute medical devices in Thailand?
A product certificate lets that product be sold, but the Act allows the Minister to designate device groups whose sellers need a sales licence. Check whether your product is in such a group before distribution.
Sources
พระราชบัญญัติ เครื่อง มือแพทย์ พ.ศ. 2551และฉบับแก้ไขเพิ่มเติม (ฉบับกฤษฎีกา) · Open source · Search our archiveพระราชบัญญัติ เครื่อง มือแพทย์ (ฉบับที่ 2)พ.ศ. 2562(ราชกิจจานุเบกษา) · Open source · Search our archiveกฎกระทรวง การจดแจ้งและ การออกใบรับ จดแจ้งผลิตหรือ นำเข้าเครื่อง มือแพทย์ พ.ศ. 2563 · Open source · Search our archiveกฎกระทรวง การแจ้งรายการ ละเอียด และการการออก ใบรับแจ้งรายการ ละเอียด ผลิตหรือนำเข้า · Open source · Search our archiveกฎกระทรวง การขออนุญาต และการออกใบ อนุญาต ผลิตหรือนำเข้า เครื่อง มือแพทย์ พ.ศ. 2563 · Open source · Search our archiveประกาศ สำนักงาน คณะกรรมการ อาหาร และยา เรื่อง กำหนดข้อมูล เอกสาร หรือหลักฐานที่ ไม่ต้องแจ้งตาม กฎกระทรวง ว่าด้วยเรื่อง การอนุญาต และการออกใบ อนุญาตผลิ · Open source · Search our archiveคู่มือแนวทาง สำหรับ ขึ้นทะเบียน เครื่อง มือแพทย์ IVD · Open source · Search our archiveแนวทาง การจัดเตรียม เอกสาร สำหรับ เครื่อง มือแพทย์ non-IVD · Open source · Search our archiveรายการ ตรวจสอบแนวทาง เอกสาร Full-CSDTเครื่องมือแพทย์ Non-IVDทั่วไป Class 2, 3และ 4รหัส NON-IVD-C-GMD-01 Rev.2ลงวันที่ 25.06.2567 … · Open source · Search our archiveคู่มือการจัดทำเอกสาร full csdt · Open source · Search our archiveแนวทาง กองควบคุม เครื่อง มือแพทย์จัดทำ Declaration of Conformityสำหรับ เจ้าของ ผลิตภัณฑ์ หรือผู้ผลิต ไม่ระบุวันมีผลแยกต่างหาก … · Open source · Search our archiveระเบียบ สำนักงาน คณะกรรมการ อาหาร และยา พ.ศ. 2550เรื่องหนังสือ รับรอง ที่ใช้นำเข้าเครื่อง มือแพทย์ และกรณียกเว้น ไม่ต้องแสดง ณด่านอาหารและยา … · Open source · Search our archiveกลุ่มเครื่อง มือแพทย์ หรือเครื่อง มือแพทย์ ที่ผู้ผลิตหรือผู้นำ เข้าต้องจดแจ้ง · Open source · Search our archiveกลุ่มเครื่อง มือแพทย์ หรือเครื่อง มือแพทย์ ที่ผู้ผลิตหรือผู้นำ เข้าต้องได้รับ อนุญาต · Open source · Search our archiveตามประกาศ สำนักงาน คณะกรรมการ อาหาร และยา เรื่อง หลักเกณฑ์ ในการจัดกลุ่ม เครื่อง มือแพทย์ · Open source · Search our archiveคู่มือกองควบคุม เครื่อง มือแพทย์ รวมกลุ่ม IVDสำหรับผู้ยื่นคำขอ ในเล่มระบุพิมพ์ครั้งแรกปี 2566อ่านสารบัญ และเลือก ส่วนเงื่อนไข กลุ่มกับตัวอย่าง … · Open source · Search our archiveกฎกระทรวง การขออนุญาต และการออกใบ อนุญาต ขายเครื่อง มือแพทย์ พ.ศ. 2555 · Open source · Search our archiveประกาศ กระทรวง สาธารณสุข เรื่อง ระบบคุณภาพ การนำ เข้าหรือขายเครื่อง มือแพทย์ พ.ศ. 2566 … · Open source · Search our archive
This article is for general information. It is not a Thai FDA ruling or legal advice, and rules change — check the latest notification or ask an expert before filing or producing.
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