Bangladesh CFS Combination Rules by Class: Origin and Reference Country

1. Key takeaways

The CFS combination required in Bangladesh is determined by the four risk classes: Class A and Class B need only one country-of-origin CFS, while Class C and Class D need two — the country-of-origin CFS plus a reference country CFS. What all four classes share is that every CFS must be attested by the Embassy of Bangladesh in the issuing country; for Class B/C/D, originals must additionally be provided at the final review stage.

• Class A: country-of-origin CFS required; reference country CFS not required; embassy attestation required (practical estimate).
• Class B: country-of-origin CFS required; reference country CFS not required; embassy attestation required; original required at final review (practical estimate).
• Class C: country-of-origin CFS required; reference country CFS required (one of any EU member state / USA / Canada / Australia / Japan); embassy attestation required for both; originals required for both at final review (practical estimate).
• Class D: identical to Class C — origin CFS, reference country CFS, attestation of both, and originals of both at final review (practical estimate).
• Guidelines-level basis: §4.6 requires QMS certification issued by a notified body for Class B/C/D (Class D additionally with design certification); §4.7 requires manufacturers holding foreign NRA / notified body QMS and product certifications or foreign marketing approvals to submit these documents for DGDA consideration.

2. Legal basis

The table below sets out the CFS combination rules for each class, followed by the Guidelines provisions that support the underlying documentation architecture. The combination figures themselves rest on registration practice, while §4.6 and §4.7 of the DGDA Medical Device Registration Guidelines establish the QMS certification and foreign-document submission requirements that frame why these certificates are collected at all.

Basis at the Guidelines level: §4.6 requires QMS certification issued by a notified body for Class B/C/D (with design certification added for Class D); §4.7 requires manufacturers that have obtained foreign NRA / notified body QMS and product certifications, or foreign marketing approvals, to submit these documents for DGDA consideration.

3. Expert insights

Insight one: the CFS and the CE certificate are parallel requirements, not substitutes for each other. In the practical checklist, the CE certificate (evidence A), the country-of-origin CFS (evidence B) and the reference country CFS (evidence C) are listed as separate items. Chinese-language materials often say “a CE certificate is enough”, but in fact the CE certificate is conformity assessment evidence, while the CFS is market access status evidence — the two prove different facts. A notified body certificate demonstrates that the product passed a conformity assessment; a free sale certificate demonstrates that a regulatory authority has allowed the product on its market. Bangladesh asks for both, and treating one as covering the other is a planning error that surfaces only at review.

Insight two: the “two certificates” for Class C/D carry two layers of meaning, and they are easily confused. The first layer is the number of documents (two CFS documents); the second is the number of countries (two different countries: the country of origin plus a reference country). In practice, the Class C/D requirement is frequently expressed as “FSCs from two countries must be provided”. A company that misreads this as “two copies from the same country” will be returned outright at the final review. The distinction sounds trivial, but it determines where in the world the second certificate must be sought, how long the attestation chain is, and how the logistics of the original documents are organised.

Insight three: embassy attestation takes place in the CFS issuing country, not in China. If the reference country is Germany (an EU member state), the reference country CFS must complete Bangladesh embassy attestation in Germany; the country-of-origin CFS completes attestation in China. These two chains run in two different countries: they can proceed in parallel in time, but the cost is doubled. Planning both chains through a single office, or assuming that one attestation covers both certificates, will misalign the calendar. The correct model is two independent attestation pipelines, each with its own notarisation, foreign ministry and embassy stages, converging only when the originals reach Bangladesh.

4. Practical recommendations

• Draw a “CFS matrix” for every project: the horizontal axis is the country of origin and the reference country; the vertical axis is the five nodes of issuance, notarisation, foreign ministry authentication, embassy attestation and courier delivery to Bangladesh; annotate every cell with the responsible person and the expected completion date.
• Advise clients to bring CFS validity into the review scope: a CFS normally carries an issue date, and if embassy attestation takes so long that the certificate has expired at the time of submission, everything done before it is wasted.
• For Class C/D, require the client to confirm the availability of the reference country CFS before deciding whether to submit at all.
• Confirm the CFS quantity per class before filing: one document for Class A/B, two documents from two different countries for Class C/D.
• Re-verify the number of originals before the final review, which for Class C/D means two originals.

5. Verification checklist

• □ The number of CFS documents has been confirmed per class: one for Class A/B, two for Class C/D
• □ The two CFS documents for Class C/D come from two different countries (country of origin plus reference country)
• □ Each CFS has a planned five-node chain: issuance, notarisation, foreign ministry, embassy, courier
• □ The CFS validity and issue dates have been re-checked before submission
• □ The number of originals for the final review has been verified (two originals for Class C/D)

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Bangladesh. Our team prepares dossiers to DGDA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of October 27, 2026.