Desk Review Eligibility: China Explicitly Excluded from Quality Audit Routes

1. Key takeaways

The Tanzanian quality audit guidelines, §7.2, provide a route to substitute a desk review (documentary review) for the on-site audit, and list five eligibility criteria (§7.2.1.1–§7.2.1.5):

1. §7.2.1.1 Located in a founding member of GHTF (later IMDRF) and audited by it: Australia, Canada, Japan, the European Union, the United States.
2. §7.2.1.2 Located in and audited by an IMDRF member, excluding China, Brazil and Russia, or a list updated by TMDA from time to time.
3. §7.2.1.3 Other sites determined through quality risk management.
4. §7.2.1.4 Manufacturing sites audited and approved by the WHO prequalification programme, MDSAP (excluding Brazil and China), EMA and any other regional harmonization initiative recognized by TMDA.
5. §7.2.1.5 Any public interest reason.

Core conclusion: China is explicitly excluded in two places, §7.2.1.2 and §7.2.1.4. Chinese manufacturers cannot rely on NMPA system evidence to claim a desk review, and should prepare for an on-site audit, unless they separately obtain an MDSAP certificate or system evidence recognized by an EU notified body or EMA.

This distinction matters commercially as well as procedurally: the default planning assumption for a Chinese site determines budget, timeline and travel arrangements, and getting it wrong at the start of a project is far more costly than correcting it early.

2. Legal basis

3. Expert insights

Insight 1: The exclusion appears twice, with precise wording — this is not failure to list; it is explicit exclusion.

The structure of §7.2.1.2 reads “Located and audited by members of IMDRF excluding China, Brazil and Russia”; the structure of §7.2.1.4 reads “Manufacturing sites audited and approved by… MDSAP (excluding Brazil and China), EMA…”. This differs from the situation in Kenya: the reference authority list of the Kenyan PPB merely does not include China, whereas Tanzania explicitly excludes it. As a matter of legal interpretation, an explicit exclusion is considerably harder to circumvent by analogy than an omission from a list.

Insight 2: What is excluded is the country route, not the company — third-party evidence can still open the desk review.

Two viable routes exist for Chinese manufacturers. First, obtain an MDSAP certificate — but note that under §7.2.1.4 the MDSAP item excludes “Brazil and China”, which should be read as excluding audits issued with Brazil’s ANVISA and China’s NMPA as participating authorities; whether an MDSAP certificate can in practice support a desk review claim for a Chinese site must be confirmed with TMDA in writing, and GRZAN does not make affirmative commitments on this externally. Second, obtain an ISO 13485 certificate issued by an EU notified body, since §7.2.1.1 covers the EU as a founding member jurisdiction and §7.2.1.4 covers EMA.

Insight 3: The desk review requires 15 pieces of evidence — the preparation workload exceeds hosting an on-site audit.

§7.2.2.1–§7.2.2.15 set out the full documentation requirements:

1. A certified copy of the ISO 13485 certificate of conformity issued by an SRA, a notified body or WHO (with certified translation if not in English);
2. A copy of the valid manufacturing licence issued by the national regulatory authority;
3. A list of all regulatory authorities that conducted on-site quality audits within the past 3 years;
4. Notarized copies of audit reports issued within the past 3 years by SRAs, notified bodies, MDSAP, other regional harmonization initiatives and/or the WHO prequalification programme;
5. The annual product quality review report — for single-use devices, ideally 25 batches produced within the past 36 months, or 10 batches produced within the past 12 months;
6. A copy of the validation master plan;
7. The process validation report for one of the devices to be registered in Tanzania;
8. The medical devices file for each model of device for which marketing authorization is sought;
9. The sterilization method validation report, where applicable;
10. Qualification, maintenance and calibration reports for key production and quality control equipment related to the devices under application;
11. The device master record (DMR) and the executed production documents for the most recent batch of the device to be registered;
12. Summary reports of internal audits for the past 3 years;
13. The company’s risk management framework;
14. Supplier qualification procedures and reports for key materials used in the devices to be registered;
15. The out-of-specification (OOS) handling procedure, including at least 3 OOS reports.

Insight 4: Desk review can still convert to an on-site audit, and the trigger is suspicion, not confirmation.

§9.3: for sites assessed through the desk review procedure, where a critical or major non-conformity is speculated to exist, an on-site audit shall be arranged. The threshold of speculation is low. Even when pursuing the desk review route, therefore, the site must retain full capability to host an on-site audit at short notice.

Insight 5: The batch volume requirement for single-use devices (25 batches/36 months or 10 batches/12 months) is the item most likely to stall an application.

§7.2.2.5 uses the word “ideally”, but as a practical estimate, if the company produced fewer than 25 batches in the past 36 months, it needs to rely on the alternative measure of 10 batches in 12 months and provide an explanation. New product lines often have no data available for this item at all, and production batches must be planned well ahead of submission.

4. Practical recommendations

1. Chinese manufacturers should default to scheduling and budgeting for an on-site audit, treating desk review as an item to be pursued rather than an established route.
2. If desk review is pursued, prioritise obtaining an ISO 13485 certificate issued by an EU notified body and confirm acceptability with TMDA in writing.
3. Whether an MDSAP certificate can be used for a Chinese site must be asked of TMDA in writing; do not make affirmative statements in external documents without confirmation.
4. Assemble the 15 desk review documents 6 months ahead, focusing on OOS reports (at least 3), internal audit summaries (3 years), and the annual product quality review (25 batches/36 months or 10 batches/12 months).
5. Retain the capability to host an on-site audit to cover the §9.3 conversion mechanism.

5. Verification checklist

• □ Aware that §7.2.1.2 and §7.2.1.4 explicitly exclude China.
• □ On-site audit scheduled and budgeted (the default route for Chinese manufacturers).
• □ If desk review is pursued, the evidence held confirmed to fall within §7.2.1.1 (EU founding member jurisdictions) or §7.2.1.4 (EMA/WHO PQ).
• □ MDSAP route confirmed with TMDA in writing (no unconfirmed commitments).
• □ All 15 documents ready, with OOS at least 3, internal audits for 3 years, and batches of 25/36 months or 10/12 months checked.
• □ Capability to host an on-site audit retained to cover the §9.3 conversion.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official published texts of TMDA (the quality audit guidelines §7.2.1.1–§7.2.1.5, §7.2.2.1–§7.2.2.15, §9.3), and will be re-checked when the regulations are updated.

• Tanzania local resources: licensed Local Responsible Person (LRP) and distributor resources can be coordinated to cover online submission, sample delivery, quality audit cooperation and port clearance.
• Service capabilities: classification determination, registration and notification pathway selection, technical documentation (CSDT/STED) preparation and localization, GMDN and grouping strategy, clinical evidence organization, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fees and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.