Eight Asian Markets Compared: Submission, Validity and Language Requirements

1. Key takeaways

Across eight major Asian markets, medical device registration differs most on three dimensions: how the submission is made, how long the approval lasts, and which language is required. Bangladesh is the only one of the eight that still runs a paper submission, and it is also one of the few markets that charges the government fee per product. India and Bangladesh are the two of the eight that regulate devices as drugs. The only feature all eight share is the classification scale: all use four classes A/B/C/D, with Thailand expressing the same four as Class 1 to 4.

• Seven of the eight markets accept online submission; Bangladesh remains paper-based as of 2026.
• Approval validity follows three different models across the eight, so renewal calendars cannot be standardised across a regional portfolio.
• Bangladesh adds a fourth pattern of its own: Class A has no expiry date, while B, C and D are valid for 5 years.
• India and Bangladesh both treat a device as a drug, but by different legal routes and with different consequences for the dossier.
• On language, Bangladesh is the most permissive of the eight, subject to a documented conflict between the guideline and practitioner accounts.
• Because Bangladesh is an exception on all three dimensions, it cannot be grouped with any other market for planning purposes.

2. Legal basis

The comparison below is limited to metrics already verified in the country series for each market; the full indicator set for any single market sits in that market’s own articles.

Reading the table by row produces a different picture than by column. By row, each market looks like a set of local requirements. By column, three fault lines appear immediately: the submission column splits seven against one, the validity column splits into models rather than into individual answers, and the language column separates the markets that require a local language from those that accept English. Those three columns are the ones worth building a regional plan around, because they are the columns that determine whether documents, calendars and labels can be shared.

3. Expert insights

Insight one: submission mode is the most visible gap among the eight, and it is the root cause of the longest project timeline in Bangladesh. The other seven markets have moved to online submission; Bangladesh remained paper-based as of 2026. The difference is not about convenience. Online submission drives the cost of changing a single field close to zero, while paper submission turns the same change into re-binding and re-submission of a physical dossier. A mistake that would be corrected in an afternoon elsewhere consumes a full cycle in Dhaka, and cycles are what project schedules are made of.

Insight two: validity follows three models among the eight, not eight separate rules. The first model is a fixed 5 years with renewal, which covers Malaysia, Indonesia, the Philippines and Bangladesh for B, C and D. The second is no fixed expiry maintained by an annual fee, which covers Singapore, India and Vietnam. The third is permanent validity with a retention fee, which is India’s position. Bangladesh adds a fourth variant of its own: Class A has no expiry date, which makes it the only market among the eight with a low-risk class that is exempt from renewal altogether.

Insight three: India and Bangladesh both treat devices as drugs, but they arrive there by different routes. India notifies devices as drugs under section 3(b)(iv) of the Drugs and Cosmetics Act, 1940, and then layers a separate rule set, MDR 2017, on top of that notification. Bangladesh writes devices directly into the statutory definition and has no separate device rules. The institutional traces of the second route are visible throughout the process: formula approval, master formula, DAR and MRP are all artefacts of a drug framework applied to a device, and their presence in a Bangladesh file is not an anomaly but the predictable consequence of the legal architecture.

Insight four: on language, Bangladesh is the most permissive of the eight. Malaysia, Indonesia, Vietnam and Thailand all require labels in the local language. Singapore, the Philippines and India work in English. For Bangladesh, guideline §7.2 does not require Bangla, and practitioners interviewed also state that English is sufficient; a point covered in article 28 of this series, where the two accounts conflict and the position is recorded as pending verification. The practical reading is that English labelling is workable today, but that the conclusion rests on a guideline reading plus practitioner accounts rather than on a single unambiguous published requirement.

Insight five: the single shared feature is the classification scale, and it is thinner than it looks. All eight use four classes, but the number of classes does not tell you whether a device lands in the same class in two markets, nor whether the class carries the same obligations. Thailand numbers the same four bands as Class 1 to 4, and Bangladesh applies a different validity rule to Class A than to B, C and D. Class alignment across markets is therefore an assumption to be tested product by product, not a starting point for a regional registration plan.

4. Practical recommendations

When supporting a multi-country rollout, we first group the markets by three criteria: submission mode, validity model and language requirement. Markets that share online submission can share one electronic document system; markets that share the five-year renewal model can share one renewal calendar. Bangladesh is an exception on all three, so it cannot be folded into any group; it has to be scheduled separately, documented separately and have its certificates managed separately. That is why we treat Bangladesh as a stand-alone market rather than as part of a packaged South-East Asia programme.

• Confirm the submission mode of each target market before building a document plan, and treat Bangladesh as paper-based.
• Group renewal calendars by validity model rather than by geography, so that the five-year markets share one calendar and the annual-fee markets share another.
• Prepare labels against the language requirement of each market, and for Bangladesh use English while seeking written confirmation for household devices.
• Schedule Bangladesh as a separate workstream with its own milestones, rather than as a line in a regional plan.
• Consult the country-specific article for the full indicator set of any market before committing to a date.
• Date-stamp the comparison table at 2026-10-27 and re-verify before reuse in a client document.

5. Verification checklist

• □ The submission mode of each target market is confirmed, with Bangladesh recorded as paper-based
• □ Renewal calendars are grouped by validity model rather than by region
• □ Labels are prepared to each market’s language requirement, with Bangladesh in English and household devices subject to written confirmation
• □ Bangladesh is scheduled as a stand-alone market
• □ The country-specific article has been consulted for the detailed indicators of each market
• □ The comparison data is marked as verified on 2026-10-27
• □ The Bangla language position is recorded as pending verification rather than as settled

Regulatory information verified as at 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