How to Verify a Certificate of Free Sale for a Medical Device: A Distributor's Guide to CFS and Export Certificates, Checking Issuing Authorities (FDA, EU, UK MHRA, NMPA) and Spotting Red Flags

Who this guide is for: distributors, importers and procurement teams evaluating export paperwork

This guide is written for international medical device distributors, regulatory affairs managers, tender officers, hospital clinical engineering committees, and private-label/OEM buyers who have been handed a Certificate of Free Sale (CFS), Free Sales Certificate (FSC), FDA Certificate to Foreign Government (CFG), or Chinese Medical Device Export Sales Certificate (医疗器械出口销售证明). In international device commerce, this document is routinely demanded by national regulatory agencies (such as ANVISA in Brazil, COFEPRIS in Mexico, SFDA in Saudi Arabia, MDA in Malaysia, or BPOM in Indonesia) as a mandatory prerequisite for product registration, import permit issuance, customs clearance, and public tender prequalification.

Yet within supplier due diligence, the Certificate of Free Sale represents one of the most misunderstood documents in medical device trade. Importers frequently assume that because a document carries an official-looking stamp, government seal, or consular ribbon, it guarantees that the device is clinically proven, rigorously inspected, cleared for domestic sale in the exporting country, and manufactured under audited quality controls. In practice, a CFS is a narrow marketability attestation. Worse, fraudulent, expired, altered, chamber-issued, and out-of-scope export certificates circulate widely in international tenders.

This guide provides a systematic, field-by-field verification methodology across the four major exporting jurisdictions: the United States (FDA CDRH), the European Union (MDR Member State Competent Authorities), the United Kingdom (MHRA), and China (NMPA and provincial MPAs). It establishes exact protocols to authenticate certificates online, verify statutory identifiers, catch scope mismatches, navigate the recent 2026 regulatory reforms, and identify disqualifying red flags before submitting documentation to local health authorities.

What a certificate of free sale actually certifies (and what it never proves)

At its core, a Certificate of Free Sale is a formal statement issued by a recognized government body or competent authority attesting that the named medical device is legally manufactured, placed on the market, or eligible for export from the territory of the issuing authority. Its primary historical purpose is to reassure foreign health ministries that an exporter is not dumping substandard or prohibited medical equipment abroad that cannot legally be sold in its country of origin.

To conduct rigorous due diligence, an importer must maintain a strict understanding of the five fundamental legal and technical boundaries of any free-sale document:

1. A CFS is not an authorization to sell in your local market: An FDA CFG or an EU CFS proves only that the device meets US or European regulatory criteria for domestic marketing or export. It confers zero legal authorization to distribute the device in Colombia, Egypt, Vietnam, or any other importing country. Local market entry requires independent registration with your national health authority.
2. A CFS is not proof of superior clinical safety or efficacy: Regulators do not conduct device testing or clinical trial evaluations when issuing a CFS. The authority verifies that the applicant has completed the requisite administrative and conformity assessment filings (such as holding a 510(k) clearance or CE certificate), but the certificate itself is not a clinical endorsement.
3. A CFS is not a Quality Management System (QMS) audit certificate: A free-sale certificate attests to legal market status, not the ongoing operational compliance of a manufacturing cleanroom. Importers must independently evaluate quality system compliance, as detailed in our guide on checking a supplier's ISO 13485 certificate and its accreditation chain.
4. A CFS is not a substitute for primary product authorization files: An export certificate is downstream evidence. It is only as valid as the underlying primary registrations. If a supplier shows you an FDA CFG, you must still independently cross-check the primary premarket notification using our guide to verifying an FDA 510(k) clearance and telling clearance, registration and listing apart. If the supplier shows an EU CFS, you must verify the underlying CE certificate using how to verify a CE certificate and its notified body before trusting an EU free-sale certificate. If sourcing from China, you must verify the underlying NMPA registration certificate rather than relying on the export certificate alone.
5. A CFS does not establish legal ownership or patent freedom to operate: A certificate lists the applicant of record and manufacturing site, but it does not resolve IP disputes, trademark rights, or OEM subcontracting boundaries.

How to verify an FDA export certificate (CFG, 801(e)(1), 802) in 2026

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issues export certificates to facilitate foreign registration of US-manufactured or US-distributed devices. A fundamental point of confusion for foreign buyers is nomenclature: the US FDA does not issue a document titled 'Certificate of Free Sale' for medical devices ². If a supplier presents a document headed 'FDA Certificate of Free Sale', it is either a non-medical commodity document or an outright forgery.

The four types of CDRH export certificates

Under section 801(e) and section 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), CDRH issues four distinct types of export certificates ^{1 2}:

1. Certificate to Foreign Government (CFG): Issued for medical devices that are legally marketed in the United States. This requires that the device has an active 510(k) clearance, De Novo classification, PMA approval, or is 510(k)-exempt; the manufacturing establishment is actively registered under 21 CFR Part 807; the device is listed; and the facility is in substantial compliance with the Quality Management System Regulation (QMSR / 21 CFR Part 820) and not subject to pending injunctions or seizures.
2. Certificate of Exportability under Section 801(e)(1): Issued for devices that are not approved or cleared for marketing in the United States (such as devices manufactured solely for foreign markets or unapproved modifications). To qualify, the device must accord to the foreign purchaser's specifications, not conflict with the laws of the importing country, be labeled 'FOR EXPORT ONLY' on the shipping package, and not be sold or offered for sale in US domestic commerce.
3. Certificate of Exportability under Section 802: Issued for unapproved or uncleared Class III or implantable devices intended for export to Tier 1 countries (such as Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, EU/EEA member states) or exported under specific statutory criteria where the manufacturing facility complies with cGMP/QMSR.
4. Non-Clinical Research Use Only Certificate (NCR): Issued for non-clinical research use only products, materials, or components not intended for human use.

Distributors must never confuse a Certificate of Exportability under Section 801(e)(1) or Section 802 with a Certificate to Foreign Government (CFG). While a CFG attests that the device is legally sold in US hospitals and clinics, a Certificate of Exportability confirms that the device is legally exported from the US but is prohibited from domestic sale in the United States.— FDA CDRH Export Guidance & FD&C Act Statutory Definitions

The 2024–2026 electronic transition: FECV validation and the CECV retirement

A critical verification reality separates modern due diligence from obsolete procedures: the complete digitization of CDRH export certificates ¹.

Effective January 2, 2024, CDRH transitioned all medical device export certificates to electronic downloadable PDFs generated through the CDRH Export Certification Application and Tracking System (CECATS). Each electronic certificate is embedded with secure digital verification features, including a unique certificate number, a direct validation web address (URL), and a Quick Response (QR) code displayed at the bottom of each certificate ¹.

Foreign regulators, distributors, and procurement teams must authenticate these certificates using the FURLS Export Certificate Validator (FECV). Scanning the QR code or opening the validation URL printed on the certificate pulls the record directly from FDA databases. Per the FDA, the results displayed are the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate, together with an image of the certificate itself ¹. Two practical consequences follow: the establishment name on the FECV record must match the manufacturer named on the document you were given, and the device-to-RFQ scope match still depends on reading the certificate's product attachment pages — FECV confirms the document is genuine and in effect, not that it covers your specific purchase.

The Retirement of the Legacy CECV Database: Historically, FDA maintained the CDRH Export Certificate Validation (CECV) database to verify paper certificates issued prior to 2024. That legacy database "will remain active until January 2, 2026" ¹, after which it was retired. Consequently, as of August 2026, a physical paper certificate can no longer be authenticated through any official FDA verification system: every certificate CDRH has issued since January 2, 2024 is an electronic PDF validated in FECV, and the database that covered earlier paper certificates is gone. A supplier presenting a paper CFG today should be asked for the electronic certificate and its FECV validation URL before the document is given any weight.

Fees and Notarization Rules: Under US federal law, FDA charges a statutory user fee of $175.00 for the first export certificate and $85.00 for each subsequent certificate issued from the same request ¹. Importers should note that the FDA does not notarize export certificates. If an importing health ministry mandates legalisation or an apostille, the exporter must obtain an apostille through the US Department of State Authentications Office (utilizing Form DS-4191) based on the FDA electronic official seal.

Which EU member state issues a CFS, and how do you check one with no central database?

In the European Union, the issuance of free-sale certificates is governed by statutory requirements set out in Article 60 of Regulation (EU) 2017/745 (Medical Device Regulation / MDR) and Article 55 of Regulation (EU) 2017/746 (IVDR) ^{3 6}.

Statutory requirements under MDR Article 60

Under Article 60(1), upon request by a manufacturer or an authorized representative, the Member State in which the manufacturer or authorized representative has its registered place of business shall issue a certificate of free sale declaring that:

1. The legal manufacturer or European Authorized Representative (EC REP) has its registered place of business on the territory of that issuing Member State;
2. The device in question carries the CE marking in accordance with the MDR and may legally be placed on the market or put into service in the European Union;
3. Mandatory Basic UDI-DI: The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the European database on medical devices (Eudamed) under Article 29;
4. Mandatory Notified Body Certificate Identification: Where a Notified Body has issued a conformity assessment certificate pursuant to Article 56 (for Class Is, Im, Ir, IIa, IIb, and III devices), the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body.

These statutory mandates provide the buyer with a deterministic verification checklist. If an EU CFS presented by a supplier in 2026 lacks the Basic UDI-DI or fails to cite the Notified Body's unique certificate number for a Class II or III device, the document does not conform to MDR Article 60 and should be rejected.

The decentralized EU structure: Why Eudamed does not store national CFS files

A widespread misconception among international distributors is that EU free-sale certificates can be searched in Eudamed. Eudamed does not store, issue, or validate national Certificates of Free Sale ^{3 7}. Eudamed registers economic operators (Actors / Single Registration Numbers), device records (UDI/Device module), and Notified Body conformity certificates (Certificates module), but national CFS documents are issued independently by each Member State's National Competent Authority (such as AEMPS in Spain, ANSM in France, BfArM in Germany, Läkemedelsverket in Sweden ⁸, HPRA in Ireland, or FAMHP in Belgium).

To verify an EU CFS, the distributor must execute a four-step cross-check:

1. Confirm the Issuing Member State Jurisdiction: Verify that the issuing Competent Authority corresponds exactly to the country where the manufacturer (if EU-based) or the European Authorized Representative (EC REP, if the manufacturer is outside the EU) has its registered commercial address.
2. Verify the European Authorized Representative (EC REP): If the supplier is located in China, the US, or elsewhere outside Europe, check that the EC REP named on the CFS is an active legal entity registered with that specific Member State's authority.
3. Cross-Check the Notified Body Certificate on NANDO: Take the unique Notified Body certificate number printed on the CFS and verify it directly with the issuing Notified Body and via the European Commission's NANDO database, following our guide to verifying a CE certificate and its notified body before trusting an EU free-sale certificate.
4. Reconcile the Basic UDI-DI: Confirm that the Basic UDI-DI on the CFS matches the manufacturer's technical documentation, Declaration of Conformity, and UDI labeling.

Status of the Article 60(2) Model Format: Under MDR Article 60(2), the European Commission is empowered to establish a standardized model CFS via implementing acts. As of August 2026, while the Competent Authorities for Medical Devices (CAMD) has endorsed standardized Q&A guidance and common text modules ⁷, national layout templates continue to vary across Member States. Verification must therefore focus on statutory content requirements rather than superficial visual formatting.

How to verify a UK MHRA certificate of free sale

Following the UK's departure from the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) issues Certificates of Free Sale for medical devices exported from Great Britain and Northern Ireland under UK medical device regulations ⁴.

To verify a UK MHRA free-sale certificate, distributors must understand the strict statutory constraints under which the MHRA operates:

1. Applicant Eligibility: The MHRA issues CFS documents only for UK exporters (specifically UK manufacturers, designated UK Responsible Persons / UKRP, or Northern Ireland Authorized Representatives) ⁴. A foreign manufacturer without an established UK entity or UKRP cannot be the direct recipient of an MHRA CFS.
2. Mandatory DORS Precondition: The MHRA will only issue a CFS for devices that are actively registered on the MHRA Device Online Registration System (DORS). If a device has not completed DORS registration, no valid MHRA certificate can exist.
3. Electronic Format and Digital Signature: Modern MHRA certificates are delivered electronically as secure PDF documents featuring an official digital signature and standard security elements.
4. The MHRA Non-Endorsement Declaration: MHRA official guidance explicitly emphasizes: 'A CFS should not be taken as a government endorsement of any product that is referred to on the certificate' ⁴. The certificate attests only that the device is registered with the MHRA and may be legally exported.
5. The FCDO Notarisation and Legalisation Rule: International buyers frequently require UK certificates to be apostilled or consularized by the Foreign, Commonwealth & Development Office (FCDO). Importers must note that the FCDO will not authenticate MHRA digital PDFs directly. Under official UK procedures, a registered UK Notary Public must first verify the authenticity of the certificate directly with the MHRA CFS team and notarize the document before the FCDO Legalisation Office will attach an apostille ⁴.

If a distributor encounters an ambiguous or unverified UK certificate, the MHRA publishes a direct contact route for its Certificate of Free Sale team, and the official notarisation procedure has the notary "carry out checks on the certificates with the MHRA to ascertain their authenticity" — so an unverified UK certificate can be escalated to the issuing team through the published channel ⁴.

What changed in China's export sales certificate rules in May 2026?

For distributors sourcing medical consumables, surgical devices, endoscopy equipment, or laser systems from China, the regulatory regime governing export certificates underwent its most substantial overhaul in over a decade in 2025–2026.

In December 2025, the National Medical Products Administration (NMPA) issued Announcement No. 126 of 2025, promulgating the revised 'Provisions on the Administration of Export Sales Certificates for Medical Devices' (医疗器械出口销售证明管理规定), which entered into official legal force on May 1, 2026, replacing the outdated 2015 provisions ⁵.

The new two-type certificate structure: Domestic registration vs. export-only manufacturing

The most consequential reform introduced by Announcement No. 126 is the explicit bifurcation of export sales certificates into two distinct administrative categories ⁵:

1. Type I Export Sales Certificate (Products with Domestic Registration/Filing): Issued for medical devices that have obtained an active Medical Device Registration Certificate (医疗器械注册证 for Class II/III) or Medical Device Filing Record (医疗器械备案凭证 for Class I) in China, and where the manufacturer holds an active Medical Device Production License (医疗器械生产许可证). This certificate confirms that the device is legally approved and marketable within China's domestic healthcare system.
2. Type II Export Sales Certificate (Products Manufactured Solely for Export): Issued for medical devices produced in China solely for foreign export that do not hold domestic Chinese registration or filing. Under the 2026 provisions, Chinese contract manufacturers and OEM/ODM exporters can legally obtain an official provincial export certificate provided they hold an active Medical Device Production License or production filing whose scope covers the product's sub-directory and first-level product category, meet China's medical device Good Manufacturing Practice (生产质量管理规范) production requirements, and sign an applicant commitment that the exported product complies with the laws of the importing country (region).

The Critical Due Diligence Rule for Chinese Sourcing: Since May 1, 2026, holding an official Chinese Medical Device Export Sales Certificate no longer implies that the device is approved or registered for domestic clinical use in China. Importers who require proof of domestic clinical clearance must inspect the certificate type, check the listed registration certificate number, and independently verify the underlying NMPA registration certificate rather than relying on the export certificate alone.— NMPA Announcement No. 126 of 2025 & Regulatory Interpretation

Provincial administration, electronic issuance, and validity limits

Under Announcement No. 126, export certificate administration is handled directly by provincial-level Medical Products Administrations (省级药品监督管理部门, such as the Shandong MPA, Jiangsu MPA, Guangdong MPA, or Zhejiang MPA). Each provincial authority sets its own handling procedure within a statutory maximum of 20 working days (on-site inspection and rectification time excluded), online processing is encouraged, and provinces publish their own implementing rules ⁵.

Key operational parameters that distributors must verify include:

1. Earliest-Expiring Validity Cap: The validity period of a Chinese Export Sales Certificate shall not extend beyond the earliest-expiring date among the underlying documents the enterprise submitted (such as the Medical Device Registration Certificate or the Production License), and for Class I devices the validity period must not exceed three years. If a supplier presents an export certificate with a validity date extending beyond its underlying production license, the certificate is legally invalid.
2. Electronic Verification Portals: Electronic and paper certificates carry the same legal force, and each provincial authority must publicize certificate information within 7 working days of issuance and report it to the NMPA information centre within 15 working days. A buyer who knows the issuing provincial MPA can therefore confirm that a certificate was issued by checking that authority's published certificate information or government-services channel.
3. Manufacturer Accountability: The 2026 regulations place strict legal liability on the manufacturing enterprise for the truthfulness of export filings. Where an enterprise obtains a certificate through false materials or deception, or alters or forges a certificate, the issuing authority voids the certificate by public notice, records the violation in the enterprise's credit file, and refuses new export certificates for five years; suspected crimes are referred for prosecution.

Chamber of Commerce CFS vs. Regulatory Health Authority Certificate: Why importing authorities reject chamber documents

A frequent pitfall in international procurement is the submission of a Chamber of Commerce Certificate of Free Sale in place of a government health authority document ⁹. In the United States, Europe, and the UK, commercial exporters who do not qualify for or wish to bypass regulatory health authority review can easily obtain a generic 'Certificate of Free Sale' from a local chamber of commerce (such as the American World Trade Chamber of Commerce / AWTCC or regional chambers) upon paying a nominal administrative fee and submitting an exporter affidavit.

Importers must understand why chamber-issued certificates represent a severe regulatory risk:

1. No Regulatory or Technical Scrutiny: A chamber of commerce is a private or quasi-public trade association, not a public health authority. It possesses no technical competence, conducts no quality audits, and performs zero verification of medical device safety, classification, or cGMP compliance. It merely notarizes the exporter's self-declaration.
2. Rejection Risk in Medical Device Licensing: Many national medical device regulators require free-sale evidence to come from the device regulator of the exporting country (such as the FDA, an EU Member State competent authority, the UK MHRA, or China's provincial MPAs) rather than from a chamber. Where that document-source rule applies, submitting a chamber certificate triggers deficiency queries, rework, and tender delays. Confirm the document-source requirement for your target market before accepting a chamber-issued CFS.
3. Legitimate Scope of Chamber Certificates: Chamber-issued CFS documents are intended strictly for non-regulated consumer goods, general industrial commodities, cosmetics, or food items where no statutory health authority exists. They have zero legal standing for regulated sterile, implantable, or invasive medical devices.

Scope-to-RFQ matching: How to ensure the certificate covers the exact device you are buying

Even when a Certificate of Free Sale is proven authentic and issued by a legitimate health authority, distributor due diligence is only half complete. The most common commercial failure mode is a scope mismatch—where the certificate is genuine, but the specific device model, catalog number, or manufacturing site in your commercial purchase order is entirely absent from the certificate's legal coverage.

To establish complete scope alignment, execute the five-point match against your quotation and RFQ:

1. Legal Entity and Registered Address: Confirm that the legal manufacturer named on the certificate exactly matches the contracting entity on your proforma invoice. If the quotation comes from a trading company, distributor, or offshore subsidiary, verify whether the manufacturer has authorized the exporter and whether the certificate lists the actual manufacturing entity.
2. Physical Manufacturing Facility: For sterile single-use devices (such as disposable circumcision staplers or laser fibers), ensure the physical manufacturing site listed on the certificate matches the facility evaluated during quality audits and registered with local customs.
3. Device Trade Name and Generic Classification: Verify that the proprietary brand name (e.g., disposable circumcision ring or endovenous laser fiber) and generic product nomenclature match the commercial packaging and local registration dossier.
4. Specific Catalog Numbers, Sizing Codes, and Attachments: In complex product lines (e.g., circumcision devices offered in a dozen or more size codes, or laser fibers offered with multiple tip geometries), inspect the certificate's attached product schedules. Ensure each individual catalog number (REF/SKU) intended for importation is explicitly listed.
5. Statutory Device Identifiers: For EU supply, match the Basic UDI-DI and Notified Body Certificate Number printed on the MDR Article 60 CFS against the manufacturer's Declaration of Conformity and technical file. For US supply, match the listed product lines against active FDA device listings.

Eight red flags that should disqualify a free-sale document immediately

When evaluating supplier export paperwork during distributor qualification or tender preparation, the discovery of any of the following eight red flags should immediately halt the onboarding process and trigger formal verification escalation:

1. Presentation of a Paper FDA CFG in 2026: If a supplier presents a physical paper FDA Certificate to Foreign Government claiming recent issuance in 2025 or 2026, it is fraudulent. All legitimate CDRH export certificates issued since January 2, 2024, are downloadable electronic PDFs with FECV QR codes, and the legacy CECV paper database was permanently retired on January 2, 2026 ¹.
2. Validity Date Post-Dating the Underlying Registration: A CFS whose expiration date extends beyond the expiration date of the underlying CE certificate, NMPA production license, or local establishment registration is invalid or must at minimum be escalated. In China, Announcement No. 126 caps certificate life at the earliest-expiring underlying licence (with a three-year outer limit for Class I devices) ⁵; in the EU, a free-sale certificate that outlives the notified-body certificate it cites is a mismatch to raise with the issuing authority ³.
3. Omission of Mandatory Basic UDI-DI on an EU MDR Certificate: An EU certificate of free sale issued under Regulation (EU) 2017/745 Article 60 that fails to state the device's Basic UDI-DI or omits the Notified Body's unique certificate identification number for a medium- or high-risk device fails statutory content requirements ³.
4. Chamber of Commerce Certificate for Regulated Sterile Devices: Presenting a certificate issued by a regional Chamber of Commerce or trade association for an invasive surgical device, implant, or sterile consumable is a major red flag indicating that the supplier lacks legitimate regulatory clearances from national health authorities.
5. Broker or Trading Entity Listed as Legal Manufacturer: If an export certificate names an export trading agency or third-party broker as the 'manufacturer' when that entity owns no manufacturing facilities or design files, the certificate will be disqualified by foreign regulatory reviewers.
6. Failure to Validate in Official Government Systems: Inability to locate an FDA certificate in the FECV system, failure to verify a UK certificate via MHRA DORS, or the absence of a provincial NMPA filing record confirms the document is illegitimate.
7. Graphic and Text Manipulation Artifacts: Visual inspection revealing mismatched font types, misaligned text lines, blurred authority seals, altered dates, or generic copy-pasted product schedules indicates digital PDF forgery.
8. Conflating China Type II Export Certificates with Domestic Registration: A supplier presenting a Chinese export certificate for a product lacking domestic registration and marketing it as 'approved in China' violates regulatory transparency. Importers must independently verify whether the product holds a Type I or Type II certificate under the May 2026 rules ⁵.

The distributor's step-by-step CFS verification workflow

To protect your business from regulatory penalties, customs seizures, and tender disqualifications, implement this five-stage verification workflow for every export document received from an overseas device supplier:

In structuring a complete market-entry dossier, export certificates should be properly sequenced behind primary clinical and technical registrations. For a practical example of how free-sale certificates integrate into a complete device submission, see the market-entry evidence pack for disposable circumcision devices shows where free-sale documents fit in the full sequence.

Where VEMERIX fits—and where distributor due diligence begins

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care. We manufacture and supply high-precision single-use surgical consumables, including our NMPA-registered disposable circumcision device platform (Circumcision Device, Circumcision Anastomat Kit, Circumcision Stapler), our NMPA-registered Disposable Medical Laser Fiber for 1470 nm endovenous laser workflows, negative pressure wound therapy systems (NPWT Pump and NPWT Dressing), wound care formulations, and sterile procedure kits.

In international distributor partnerships and OEM/private-label collaborations, VEMERIX adheres to an uncompromising standard of regulatory transparency. We believe that professional distributor due diligence begins with complete, independently checkable documentation:

1. Verifiable Regulatory Registrations: We provide authentic, current Medical Device Registration Certificates issued by the NMPA, CE certificates issued by designated Notified Bodies, and provincial Medical Device Production Licenses covering our manufacturing facilities in Shandong, China.
2. Compliant Export Sales Documentation: For international market authorizations, we provide officially issued, electronically verifiable Medical Device Export Sales Certificates issued by the Shandong Provincial Medical Products Administration conforming strictly to NMPA Announcement No. 126 of 2025.
3. Audited Quality System Evidence: Our facilities operate under an accredited ISO 13485:2016 quality management system (Certificate No. 10425YQ00012R0S, valid 2025–2028) covering the design, development, and manufacture of our sterile single-use surgical and wound care device families, fully verifiable via national accreditation databases.
4. Complete Technical Dossiers: We supply international distributors with comprehensive regulatory evidence packs, including biocompatibility reports (ISO 10993), sterilization validation protocols (ISO 11135 EO / ISO 11137 Radiation), accelerated aging and packaging integrity data (ISO 11607), and clinical evaluation summaries.

We invite prospective international distributors, hospital procurement authorities, and OEM partners to evaluate our product specifications and request comprehensive regulatory and export documentation packs by visiting our Products Portfolio, reviewing our quality governance at Quality Systems, or contacting our regulatory affairs team directly via Contact VEMERIX.

Frequently asked questions

Is an FDA 'Certificate of Free Sale' the same as a Certificate to Foreign Government?

No. The US FDA CDRH does not issue a document titled 'Certificate of Free Sale' for medical devices. For medical devices that are legally marketed in the United States, the FDA issues a Certificate to Foreign Government (CFG). For devices that are not approved or cleared in the US but meet statutory criteria for export, the FDA issues a Certificate of Exportability under Section 801(e)(1) or Section 802 ^{1 2}. If a supplier presents a document headed 'FDA Certificate of Free Sale', it is either an unverified third-party document, a food/cosmetic certificate from a state department of agriculture, or a counterfeit document.

How long is a Certificate of Free Sale valid, and who determines its expiration?

The legal validity of a Certificate of Free Sale is established by the issuing authority and is frequently bounded by underlying licenses. In the United States, FDA authenticates export certificates in FECV "for the time they are in effect", and the FECV record displays each certificate's expiration date; FDA's published device-export pages do not state a single fixed validity period ¹. In the EU, MDR Article 60 sets no validity period — each issuing Member State Competent Authority sets its own, so the printed validity and the issuer's published rules govern, and a certificate that outlives the notified-body certificate it cites is a mismatch to escalate ^{3 7}. In China, under NMPA Announcement No. 126 of 2025, validity is capped at the earliest-expiring underlying Medical Device Registration Certificate or Production License, and for Class I devices it must not exceed three years ⁵. On top of the issuing authority's rules, many importing health ministries impose their own maximum document age at submission — confirm the freshness rule for your market when you request the document.

Can a Chamber of Commerce CFS support a medical device import license application?

Frequently, no. Chamber of commerce certificates are based solely on exporter affidavits without regulatory review ⁹, and many national health authorities require medical device free-sale evidence to be issued directly by a government regulatory authority (such as FDA CDRH, an EU Member State Competent Authority, UK MHRA, or China's provincial MPAs). Because acceptance varies by market, confirm the document-source requirement with your regulator before submitting or accepting a chamber-issued document.

Does a Certificate of Free Sale prove that a medical device is safe or CE marked?

A CFS certifies that administrative and regulatory preconditions for legal marketing or export have been met in the issuing territory; it is not an independent guarantee of clinical safety or batch quality. While an EU CFS issued under MDR Article 60 certifies that the manufacturer holds a CE mark and sets out the Basic UDI-DI and Notified Body certificate number ³, the distributor must still independently verify the underlying CE certificate via NANDO and evaluate technical documentation to confirm device safety.

Can a Chinese manufacturer export without domestic NMPA registration and still obtain an export certificate?

Yes. Under NMPA Announcement No. 126 of 2025 (effective May 1, 2026), Chinese manufacturers can obtain a Type II Export Sales Certificate for medical devices produced solely for export that do not hold domestic Chinese registration or filing ⁵. The manufacturer must hold an active Medical Device Production License (or production filing) covering the product category, meet China's medical device Good Manufacturing Practice production requirements, and sign an applicant commitment that the exported product complies with the importing country's laws. Therefore, international buyers must never assume that an export certificate from China implies domestic clinical approval.

Does a Certificate of Free Sale require legalisation, an apostille, or notarisation to be usable abroad?

Requirements depend entirely on the destination country's legal framework. If the importing country is a party to the Hague Apostille Convention (1961), an apostille issued by the competent national authority (e.g., the US Department of State Authentications Office or the UK Foreign, Commonwealth & Development Office) is sufficient without consular legalization. If the importing country is not a Hague Convention member (e.g., various countries across the Middle East, Southeast Asia, or Africa), the certificate must undergo full consular legalization: certification by a notary public or issuing authority, authentication by the exporter's Ministry of Foreign Affairs, and final legalization by the embassy or consulate of the destination country.