The Simplified Master Formula: A Requirement of Pharmaceutical Origin

1. Key takeaways

The Bangladeshi dossier contains a document called the Master Formula, and in practice a simplified version is what gets submitted. The name is inherited rather than invented: it comes from the pharmaceutical regulatory system, and it is a direct product of the position described in the first article of this series, that a medical device is regulated as a drug. In a device context the term is normally read as a simplified statement of product composition, materials and proportions, but DGDA has published no official format for a device master formula, so the precise expectation remains pending verification.

That gap is the practical issue. The document is required, the content boundary is undefined, and the consequence is that two manufacturers can submit entirely different documents under the same heading and both can be procedurally correct. The only reliable way through is to write to the purpose of the requirement and to confirm the local expectation before submission.

• Name: Master Formula, submitted in simplified form.
• Origin: pharmaceutical administrative language, following the statutory treatment of devices as drugs.
• Content: product composition, materials and proportions, stated in simplified form.
• Format: no official DGDA template; the current expectation is pending verification.
• Anchor: where a pharmacopoeial monograph applies, guideline §7.1 gives the document a definite reference point.

2. Legal basis

The requirement sits on a statutory foundation that is pharmaceutical in character. The Drug and Cosmetics Act 2023 defines a device within the definition clause of a drug law, and the registration guideline follows that logic in its sampling provision, which directs that sampling be conducted, as far as possible, according to the procedure of the Drug Act 1940. The two-step process reinforces the same vocabulary: its first step is not called a technical review but a Recipe Approval.

None of these provisions defines what a device master formula must contain. They establish that the vocabulary of pharmaceutical licensing applies, and they leave the operational content to be settled between applicant and reviewer. That is a normal state of affairs in a system that regulates devices through drug institutions, and it rewards applicants who ask rather than assume.

3. Expert insights

Insight 1: Recipe Approval and Master Formula are two landing points of one vocabulary. The first step of Bangladeshi registration is called Recipe Approval; the document submitted within it is called the Master Formula. This is not a coincidence or a translation failure but the predictable result of devices being absorbed wholesale into the administrative language of drugs. Once that is understood, the document stops looking like an anomaly and starts looking like a form the applicant has to complete in a language that was not designed for the product. The practical consequence is that a device manufacturer should not expect the reviewer to supply a device-specific definition; the applicant has to translate the concept into device terms and defend the translation.

Insight 2: the absence of an official format is both a risk and a space. A pharmaceutical master formula has an established shape: ingredients, specification, manufacturing process. A device master formula has none. That means the applicant must judge what to include, and it means versions submitted by different companies vary widely in depth and structure. The risk is obvious, since a reviewer who expected more will ask for it and a cycle is lost. The space is equally real, because a well-judged short document avoids disclosing trade secrets that carry no regulatory value. Our approach follows a principle of responsible simplification: state the product composition, the critical materials and the critical process parameters clearly, and leave out confidential detail that the reviewer does not need in order to reach a view.

Insight 3: the pharmacopoeial provision in §7.1 is the part of the master formula requirement that lands most easily. For surgical sutures, bandages and drug-device combinations, the guideline expressly applies United States Pharmacopeia and European Pharmacopoeia monographs. Where a monograph exists, the master formula can be written against it, citing the monograph rather than restating the parameters, which produces a short, verifiable document that a reviewer can check without specialist knowledge. Where no monograph exists, the document falls back on a materials list. The distinction is worth making at drafting stage, because it determines the whole shape of the page.

Insight 4: a short document is not a weak document. The temptation, faced with an undefined requirement, is to submit a long file to demonstrate effort. In practice length invites questions. A single page that names the composition, the materials, the critical parameters and their tolerances gives the reviewer everything needed and nothing to argue about.

4. Practical recommendations

GRZAN works to a rule of simplicity where possible, completeness where necessary. Where a harmonised standard or a pharmacopoeial monograph applies, the master formula cites the standard number and the monograph name instead of copying technical parameters a second time. Where no standard applies, it lists the product composition, the critical materials, the critical process parameters and their tolerances, and is held to 1 page. Before submission we confirm with the local partner what DGDA currently expects of the document in that cycle, including whether a Bengali version or a stamped copy is wanted, and we record the answer as a pending verification item so that it is revisited rather than treated as settled.

• Choose the route by product type. Monograph citation for pharmacopoeial products, materials and process list for everything else.
• Hold to one page. A simplified version is what is asked for; length is not a substitute for judgement.
• Confirm the format each cycle. Ask the local partner in writing and file the answer with the dossier.
• Protect confidential detail. Composition at the level needed for review, not at the level needed for manufacture.
• Keep names identical. Product name, model and manufacturer must match the main dossier exactly.

5. Verification checklist

• □ It is understood that the Master Formula derives from pharmaceutical regulatory language and is not a translation error
• □ The drafting route is chosen by product type: monograph citation or materials and process list
• □ Length held to the simplified form, ideally one page
• □ Current format expectations confirmed with the local partner and marked pending verification
• □ No unnecessary trade secrets disclosed in the master formula
• □ Product name, model and manufacturer consistent with the main dossier

Regulatory information verified as of 27 October 2026.

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