Global Market History Declaration for Medical Device Registration in Ethiopia

1. Key takeaways

Ethiopia requires a Global Market History declaration to accompany the registration application, listing every country or region in which the device has been authorized for marketing (including marketing carried out under compassionate use provisions), and supported by copies of the marketing authorizations, free sale certificates or other supporting certificates issued by the regulatory authorities of those countries. The declaration serves both as the entry material for the SRA reliance route and as a routine requirement under the Full Assessment pathway — it is the single evidentiary core that both routes share.

Because the same declaration serves every pathway, its quality compounds across the whole submission strategy. A declaration that is complete, current and certificate-backed can be reused for the SRA claim, the Full Assessment file and even the low-risk abbreviated file with minimal rework. A declaration that misses markets, cites expired certificates or substitutes internal sales records for official documents fails identically in all of them — and because it is the file’s opening statement of the product’s regulatory track record, a weak first impression colors how reviewers read everything that follows.

2. Legal basis

3. Expert insights

Insight 1: the scope of the declaration includes marketing under compassionate use. The general guidelines require listing all countries or regions in which the device has been authorized for marketing, including any marketing carried out under compassionate use provisions. This class of non-routine marketing must not be omitted; an omission renders the declaration incomplete. Compassionate use authorizations are easy to overlook because they rarely produce standard registration certificates, but the obligation is explicit, and the answer is to list the country together with whatever official documentation the authorization generated.

Insight 2: the evidence requirement points to documents issued by national regulatory authorities. The declaration list must be supported by copies of the marketing authorizations, free sale certificates or other supporting certificates issued by the competent authorities of the listed countries. Internal company sales records cannot serve as evidence. The distinction matters because the declaration is a statement about regulatory recognition, not commercial activity: what the reviewer is reconstructing is where health authorities have judged the product acceptable, and only those authorities can attest to that judgment.

Insight 3: the non-IVD dossier expands global market history into four sub-items. Section 2.4 of EFDA/GDL/097 requires, in addition to the market history itself: global event reports and recalls; sales, incident and recall rates; and assessment / inspection reports. These items bring how well the product sells and what has gone wrong with it into the scope of review — a direct reflection of the new guideline aligning with World Health Organization evaluation tools. Companies accustomed to a simple market list should note that the 2026 dossier asks for quantitative post-market context as well.

Insight 4: the low-risk route likewise requires the marketing authorization status. Section 6.1.4 of EFDA-GDL-092 lists marketing authorization status in other countries as a mandatory item of the abbreviated file. This shows that global market evidence is a common requirement running through every pathway. Even where the technical review is abbreviated, the regulator still wants to see the product’s external track record — which is why the same evidence ledger should serve all pathways rather than being rebuilt per submission.

Insight 5: the declaration and the SRA route form a closed evidentiary loop. The SRA route accepts marketing authorization certificates, registration certificates or free sale certificates as reliance evidence; the global market history declaration systematically lists all markets and attaches the certificate copies. The two use the same certificates, but for different purposes — the former supports the classification of the application into a pathway; the latter supports the reviewer’s judgment of the product. Keeping the certificates indexed once, with countries, types and validity dates, serves both functions without duplication.

4. Practical recommendations

1. Compile the declaration on the Annex VII template: list every country and region of marketing.
2. Collect copies of marketing authorizations or free sale certificates in parallel: and confirm they are within their validity periods.
3. Never omit special marketing cases such as compassionate use.
4. For non-IVD submissions, prepare event and recall rates and assessment / inspection reports in addition.
5. Certificate copies must be legible with necessary translations attached: English is the working language.
6. Maintain a global market evidence ledger: by country, certificate type and validity period.

5. Verification checklist

• □ Global market history declaration completed on the Annex VII template
• □ Copies of marketing authorizations or free sale certificates for the listed countries attached
• □ Special marketing cases such as compassionate use covered
• □ For non-IVD submissions, event and recall rates and assessment / inspection reports supplemented
• □ Global market evidence ledger established and regularly updated

Regulatory information verified as of October 29, 2026. The global market history requirements and dossier entries described in this article follow Section 9.2.6 of EFDA-GDL-046 and Section 2.4 of EFDA/GDL/097; when the guidance is updated, the content must be re-verified.

• Ethiopia local resource: GRZAN supports manufacturers from the Chinese mainland and overseas in working with the Ethiopian Food and Drug Authority (EFDA) on marketing authorization (MA) applications, the institutional competency certificate (CoC) and import permit applications, including local agent scheme design and agency agreement review, SRA reliance route justification, UMDN coding and classification determination, technical dossier preparation, and vigilance and post-market surveillance system setup.
• Service capabilities: product attribute determination and risk classification (non-IVD Class I–IV / IVD Class A–D), marketing authorization applications and re-registration, low-risk notification eligibility determination, Essential Principles conformity justification, English-language labeling and instructions-for-use localization, vigilance reporting and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn. For EFDA registration pathway and classification strategy support for the Ethiopian market, write to info@grzanglobal.com.