Bangladesh Reference Country CFS Requirements for Class C and D

1. Key takeaways

Bangladesh Class C and Class D devices must submit two Free Sale Certificates (CFS): one country-of-origin CFS and one reference country CFS issued by any one of five sources — any EU member state, the USA, Canada, Australia or Japan. Both certificates must be attested by the Embassy of Bangladesh in the issuing country, and both must be provided in original form at the final review stage. For Chinese manufacturers this is the first hard gate encountered in Bangladesh: without a reference country identity, Class C/D devices effectively cannot enter the market.

• Class C/D must submit a reference country CFS: FSC from any one of the countries — EU, USA, Canada, Australia, Japan — attested by the Bangladesh Embassy and provided in original form, per item 1(b) of the “Marketing and Regulatory details” section of the DGDA Registration Guidelines for Medical Devices, Bangladesh 2015.
• Country-of-origin CFS: the FSC of the manufacturing country, attested by the Bangladesh Embassy; the same item 1(b) requires it to be submitted together with the reference country CFS.
• Class B CFS requirement: only one country-of-origin CFS is needed; no reference country CFS is required, per item 1(a) of the same section.
• Whether the UK or Switzerland can serve as reference countries: the Guidelines list does not include the UK or Switzerland; whether a UK CFS can replace “any EU member state” after Brexit must be confirmed with DGDA in writing, and this is an inference item that cannot be assumed by default.
• Consequence of a missing reference country CFS: the application is rejected at step one (practical estimate).

2. Legal basis

The table below consolidates the CFS requirements for Class C/D applications. The core obligation — a reference country FSC drawn from the five listed sources alongside the origin country FSC, both attested — is anchored in item 1(b) of the Marketing and Regulatory details section of the 2015 Registration Guidelines, while the rejection consequence rests on registration practice. The status of unlisted countries is treated as an inference item requiring written confirmation rather than a default assumption.

3. Expert insights

Insight one: the reference country CFS is a qualification threshold, not a bonus item. It does not make the review faster; it makes the application eligible to be reviewed at all. Without it, the application is rejected outright at step one and never reaches technical assessment at all. This logic is entirely different from the reasoning found in many markets, where foreign approvals merely accelerate review or earn lighter scrutiny. Companies accustomed to treating overseas certificates as optional supporting evidence need to recalibrate: in Bangladesh for Class C/D, the reference country CFS is the entry ticket, and no amount of other documentation compensates for its absence.

Insight two: both CFS documents require separate embassy attestation, so the cost and time are doubled. Bangladesh is not a party to the 1961 Hague Convention, so an Apostille cannot be used (see the dedicated article on attestation). For the same category of task — authenticating a foreign official document — China to the Philippines can already proceed through Apostille, whereas for Bangladesh the full three-stage chain of notarisation, foreign ministry authentication and embassy attestation must be completed, and it must be completed twice, once for each certificate. Project plans that budget attestation once for Class C/D projects understate both the cost and the calendar by half.

Insight three: the list is “EU plus four countries”, Canada is on it, and the UK and Switzerland are not. The text of the Guidelines lists five sources — EU, USA, Canada, Australia, Japan — and Canada is explicitly included, contrary to the circulating claim that Canada does not count. Conversely, the UK and Switzerland have never appeared on the list. After Brexit the UK no longer belongs to “any EU member state”. Clients holding UK or Swiss CFS documents should first obtain written confirmation from DGDA on whether they can substitute, rather than processing them under the assumption that the CFS of any developed country will be accepted. The gap between the formal list and market rumour is exactly where submissions fail.

4. Practical recommendations

• Open every Class C/D project with a single qualifying question: which of the five sources — the EU, the USA, Canada, Australia or Japan — do you already hold a CFS from?
• If the answer is none, present the client with two paths: first, obtain reference country market access (typically the EU CE route, the longest cycle but the most stable thereafter); or second, re-evaluate the product positioning as Class B, if the classification allows.
• Never file a Class C/D application without a reference country CFS — this is not a gamble on probability but a certain waste of a quarterly meeting cycle.
• Confirm in writing with DGDA whether a UK or Swiss CFS can substitute for the listed sources before building any plan around an unlisted country.
• Start the embassy attestation of both CFS documents as early as possible in the project calendar, since the three-stage chain must be run twice and cannot be compressed by an Apostille.

5. Verification checklist

• □ It has been confirmed that the product is Class C/D and falls within the two-CFS regime
• □ The country-of-origin CFS has been obtained and attested by the Bangladesh Embassy
• □ The reference country CFS has been obtained (one of any EU member state / USA / Canada / Australia / Japan) and attested by the Bangladesh Embassy
• □ Both CFS documents have been prepared in original form for the final review
• □ For holders of UK or Swiss CFS documents, the item of written confirmation with DGDA on substitutability has been listed
• □ The self-check has been completed to the standard of “missing reference country CFS equals rejection at step one”

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.