Certifications & Regulatory Documents
Explore our certificates, their scope and printed dates. Preview every document and annex without leaving this page.
3 documents · Issued to NJ Medical Instruments, Sialkot, Pakistan · Dates shown as printed
Certificates and documents
Details below are transcribed from each document. Dates are the ones printed on the document; this page does not confirm a document’s current status.
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Quality management system certificate
States that NJ Medical Instruments has documented and implemented a quality management system that complies with ISO 13485:2016 for the manufacture and export of surgical and dental instruments. It certifies the management system, not individual products.
Certificate details
The certificate states that its validity depends on positive results of surveillance audits.
Product conformity · Regulation (EU) 2017/745 (MDR)
Issued by Inter Frontier Certification (IFC). It states that IFC examined the technical file and declaration of conformity for the products listed in Annex I and found them to conform to Regulation (EU) 2017/745 on medical devices.
Certificate details
Products listed in Annex I (23 product types)
As printed in Annex I (category: Surgical & Dental).
- Scalpels
- Scissors
- Scalpels Blades
- Needle Holders
- Retractors
- Scalpel Handles
- Vaginal Specula’s
- Trocars
- Laryngoscope
- Bone Chisels
- Knives
- Nasal Specula
- Bone Curettes
- Bone Mallets
- Tongue Depressor
- Mouth Gags
- Uterine Dilators
- Forceps
- E.N.T Diagnostic Products
- Dental Instruments
- Orthopedic Products
- Medical Surgeries set
- Plastic surgery tools
Product conformity · Directive-based (MDD)
A companion document from Inter Frontier Certification, issued on the same day as the MDR certificate and listing the same Annex I products, that cites a council directive instead of Regulation (EU) 2017/745.
Certificate details
Products listed in Annex I (23 product types)
As printed in Annex I (category: Surgical & Dental).
- Scalpels
- Scissors
- Scalpels Blades
- Needle Holders
- Retractors
- Scalpel Handles
- Vaginal Specula’s
- Trocars
- Laryngoscope
- Bone Chisels
- Knives
- Nasal Specula
- Bone Curettes
- Bone Mallets
- Tongue Depressor
- Mouth Gags
- Uterine Dilators
- Forceps
- E.N.T Diagnostic Products
- Dental Instruments
- Orthopedic Products
- Medical Surgeries set
- Plastic surgery tools
Regulation (EU) 2017/745 repealed the Medical Devices Directive (93/42/EEC) and has applied since 26 May 2021. If a tender names a specific framework, ask us which document is relevant.
What these documents cover
All documents on this page are issued to NJ Medical Instruments at Block 4, Rashid Minhas Road, Small Industrial Estate, Sialkot, Pakistan. They do not name our USA, UK & EU or UAE inventory locations.
| Document | Type | What it covers | Product list |
|---|---|---|---|
| ISO 13485:2016 certificate 23-B-1635 Rev. 0 | Quality management system certificate | The company’s quality management system for the manufacture and export of surgical and dental instruments (technical areas A and F) | None. It certifies the management system, not specific products |
| MDR certificate of conformity CE-EU-1012153 | Product conformity document | Products listed in Annex I, assessed against Regulation (EU) 2017/745 | Annex I: 23 surgical and dental product types |
| MDD certificate of conformity CE-EU-1012154 | Product conformity document | The same Annex I products, citing a council directive | Annex I: same list as the MDR certificate |
Products and ranges
Annex I names product types such as scissors, forceps, needle holders, retractors, dental instruments and ENT diagnostic products. If a product range from our catalogue is not named in an annex, ask us before relying on these documents for it.
Destination markets
These documents do not, on their own, establish registration or approval in any particular country. Requirements differ by market, so tell us where the instruments will be supplied.
Frequently asked questions
How can I review your certificates?
Select a thumbnail, title or Preview Certificate button to open the document here. Use the page controls to view annexes and zoom to read small print.
Which products do these documents cover?
The IFC certificates of conformity list 23 product types in Annex I under the category Surgical & Dental. The ISO 13485:2016 certificate covers our quality management system for manufacturing and exporting surgical and dental instruments, and does not list individual products. For a specific instrument, contact us with the product name or SKU.
How can I confirm a document’s authenticity or current applicability?
Each card shows the issuing body and reference number as printed on the document. The dates shown are also as printed; this page does not confirm current status. You can contact the issuing body named on the certificate, or contact us for help with your supplier file.
Can I request clarification for a tender or supplier assessment?
Yes. Contact our team and include the destination country, the product names or SKUs, and the requirement from your tender or supplier questionnaire.
How can I ask about the latest document version?
When you contact us, quote the certificate number, for example CE-EU-1012153 or 23-B-1635 Rev. 0, and ask whether a newer version or revision is available.
Why are there both MDR and MDD documents?
Both were issued by Inter Frontier Certification on 9 February 2026 and list the same products. One cites Regulation (EU) 2017/745 (MDR); the other cites a council directive. The MDR has applied since 26 May 2021 and repealed the Medical Devices Directive 93/42/EEC, so tell us which framework your tender or buyer requires.