Buying medical disposables in Pakistan: DRAP checks before you order
Buyer’s checklist for medical devices in Pakistan: DRAP licence and product status, ISO 13485, CE, Free Sale Certificate, batch traceability and red flags.
In short: before buying medical devices in Pakistan, check that the supplier holds the right DRAP licence, that the product is enlisted or registered for its risk class, and that each delivery comes with batch numbers, expiry dates and a certificate of conformity. Keep these documents in the purchase file.
The regulator and the rules
Medical devices in Pakistan are regulated by the Drug Regulatory Authority of Pakistan (DRAP) under the Medical Devices Rules, 2017. Devices are grouped by risk into Class A (low risk) to Class D (high risk). Companies that import, manufacture or distribute devices need the appropriate establishment licence, and products need to be enlisted or registered according to their class.
Checklist for buyers
- Supplier licence. Ask for the importer’s Establishment Licence for Import or the distributor’s licence, and check the company name matches the invoice. ProDr imports under ELI 00850.
- Product status. Ask for evidence that the specific product is enlisted or registered with DRAP as its class requires.
- Manufacturer quality system. An in-date ISO 13485 certificate whose scope covers the product.
- Conformity marking. CE marking under EU MDR 2017/745 or another recognised approval, with the declaration of conformity.
- Free Sale Certificate. A Free Sale Certificate from the country of manufacture, often requested for public tenders.
- Product standards. Test reports or declarations for the standards that define the product — for example EN 868-5 for sterilization reels, ISO 11140-1 for indicators, AAMI EC12 for ECG electrodes.
- Per-delivery documents. Batch or lot numbers and expiry dates on the delivery note, and a certificate of conformity per consignment.
- Labelling. Labels with manufacturer, batch, expiry and storage information, using ISO 15223-1 symbols.
- Complaints and recalls. A named contact and a written process for complaints, field safety notices and recalls.
Red flags
- No batch number or expiry date on the product or delivery note.
- Certificates for a different product, size range or manufacturer than the one supplied.
- Expired ISO 13485 or CE certificates.
- A supplier who cannot say which licence the goods were imported under.
How ProDr documents supply
Each ProDr consignment is traceable by batch from import to delivery, and the desk supplies licence, registration, certificate and test documents for purchase and tender files. See compliance and documentation for the full set.