Compliance documentation is now the single most common blocker in medical device export deals. Buyers request certificates they have heard about, distributors ask for documents they may not legally need, and both sides lose weeks in email loops. This training session consolidates the 

questions our overseas customers raise most often — third-party certification costs, EU UDI registration sequence, UDI marking red lines, and the recurring "do you have a GMP certificate" request — into one clear reference framework.

Four document types are requested most frequently by importers, distributors and tender authorities. We arrange all of them, and we are explicit about who pays:

• Free Sale Certificate (FSC) — issued by the competent authority of the manufacturing country, confirming the product may be freely sold in the domestic market.
• Hague Apostille (Apostille Certificate) — single-step legalisation accepted by Hague Convention member states.
• CCPIT Stamping — commercial document authentication by the China Council for the Promotion of International Trade, regularly required for customs clearance and registration files.
• Embassy / Consulate Legalization — the final consular legalisation step required by non-Hague markets, including several Middle East and North African countries.

Cost principle: all third-party certification fees are borne by the customer and charged at cost, with no mark-up. Every document we issue in-house — declarations of conformity support, technical files, ISO 13485 copies, product documentation and specification sheets — is provided completely free of charge.

UDI projects fail most often not because of the code itself, but because the steps are executed out of sequence. The workflow below is fixed — each stage certifies the previous one:

1. Print the complete UDI code, never the DI alone. EU rules do not accept a label carrying only UDI-DI. The full code equals DI (fixed product identifier) + PI (production identifier), and the PI must include both the production batch number and the expiry date.
2. The full code changes with every batch. Because the code embeds lot number and expiry date, it can never be pre-printed as a fixed barcode. The UDI full code differs for each shipment and can only be produced online by the factory's dedicated marking machine.

Communicating these two points early prevents the most expensive rework scenario in EU projects: artwork approved, labels printed, and the entire batch rejected at the border because the label carries a fixed code instead of a batch-specific full code.

Core conclusion: GMP is not a certificate that can be applied for on its own. It is a regulatory baseline.

1. GMP is a production quality management regulation, not a certification. It is the market-entry floor for medical device manufacturing — a factory that does not meet GMP requirements cannot obtain production qualification and cannot legally start manufacturing.
2. What overseas customers call "GMP" is usually ISO 13485. In most conversations the "GMP certificate" being requested is in fact the quality management system certificate, which corresponds to our ISO 13485 certification.
3. Recommended response. Ask the customer to confirm with their local drug administration whether GMP is treated as equivalent to ISO 13485, or which specific certificate the authority requires. We can supply the complete ISO 13485 document package for their registration file.

Clear documentation and a fixed process are competitive advantages in themselves. Sales teams that can explain these four areas confidently shorten the buyer's approval cycle, reduce compliance disputes, and win tenders where documentation quality is scored.