Quality Standards
How we work, what we document, and what we won't fake.
Quality benchmarks we work to
ASQ refurbishes equipment using OEM published service specifications as the calibration target. Where ISO 13485 applies — for medical-device quality management — we follow its process principles internally for documentation, traceability, and corrective-action workflows.
Documentation produced for every unit
- Incoming inspection report with photographs
- Parts replaced with manufacturer/source records
- Calibration certificate with measured values vs. OEM spec
- Electrical safety test results (IEC 60601-1 leakage, ground continuity, dielectric strength)
- Final QA sign-off with technician name and date
- Operating manual and quick-reference guide where applicable
Regulatory environment we operate in
Pakistan medical-device imports are regulated by DRAP — the Drug Regulatory Authority of Pakistan. Our import documentation and end-customer paperwork support DRAP compliance for hospital procurement. For export markets, we work with locally-licensed importers who hold the appropriate registrations:
- UAE — Emirates Drug Establishment (EDE), which took over device registration from MOHAP in January 2025. DHA and Abu Dhabi DoH license facilities, not products.
- Saudi Arabia — SFDA Medical Device Marketing Authorisation (MDMA), filed through the GHAD system by a Saudi-licensed Authorised Representative. Refurbished units additionally require a post-refurbishment MDMA alongside the original.
- Qatar — MoPH Drug & Medical Devices Department
- Oman — MoH DGPADC
- Kuwait — Kuwait Drug & Food Control
- Bahrain — NHRA
- Bangladesh — DGDA
- Sri Lanka — NMRA Medical Devices Division
- Nepal — DDA
- Kenya — PPB
- Nigeria — NAFDAC
- Tanzania — TMDA
- Uganda — NDA
- Ethiopia — EFDA
- Sudan — NMPB
What we won't claim
We don't fabricate certifications. We don't claim OEM authorization we don't have. We don't paste logos we haven't earned. If a buyer needs a specific certification we don't currently hold, we say so upfront — and either help them find a provider who has it, or build the case for ASQ to obtain it.
This page is updated as our certifications expand. Send an inquiry for the most current documentation specific to your project.
A note on the regulator list above
Those are the authorities our importer partners register with — not registrations ASQ holds itself. We name them because device regulation in these markets changes faster than most supplier websites do, and an out-of-date regulator name is a genuine procurement risk rather than a cosmetic error. The UAE and Saudi entries above were both corrected in July 2026 for exactly that reason.
One correction worth stating plainly, because it is the single most misreported rule in our industry: there is no general “five-year rule” barring older medical equipment from import. We checked the primary regulations of eight markets and found no numeric age limit in any of them. What does exist is stricter in Saudi Arabia and more clearly defined in Nigeria and Tanzania than the folklore suggests.
Need specific documentation for your project?
Tell us your facility, country, and procurement requirements — we'll send the relevant certifications and sample documentation.