The Continuous Glucose Monitoring System (CGMS) is a non-invasive wearable that tracks real-time glucose levels around the clock, with alerts and trend data to support diabetes management. It records 24-hour glucose fluctuations for proactive care.
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Continuous Glucose Monitoring System (CGMS): What the Published Guidance Says
Infection-prevention consumables and single-use medical devices supplied alongside our pharmaceutical range, so a programme can source the medicine and the means to deliver it safely from one supplier.
Continuous Glucose Monitoring System (CGMS) is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Devices & Antisepsis range overview.
- WHO has issued a global alert on chlorhexidine misadministration WHO has recorded more than 40 cases since 2015 of serious eye injury, including blindness, where chlorhexidine gluconate 7.1% was mistaken for an eye drop or ointment. Its recommendations include selecting container designs that distinguish the product from other medicines typically used for newborns, updating the label with safe-use information, and developing clear instructions for users. WHO — Chlorhexidine 7.1% digluconate: reports of serious eye injury (Information Notice, Aug 2020)
- Diagnostic contrast media are listed medicines The Model List includes diagnostic medicines such as barium sulfate and meglumine iotroxate — a reminder that contrast agents, including our iopamidol injection, sit inside the medicines regulatory framework rather than the device framework. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- MSF's handling rules for cord-care chlorhexidine MSF specifies the 7.1% gel for the umbilical cord only, states it must not be used on other parts of the body, warns against combining it with soap or other antiseptics such as povidone-iodine because of incompatibility, and notes the 3 g single-dose presentation is preferred over the 20 g tube to reduce contamination from opened tubes. MSF Essential Drugs — Chlorhexidine 7.1% dermal gel
These points are quoted because they shape how Continuous Glucose Monitoring System (CGMS) is specified, labelled and purchased — including strength selection, pack size and the artwork wording. Confirm each one against the approved product information in your market before finalising a purchase order.
Continuous Glucose Monitoring System (CGMS) — Supply Parameters
| Product Name | Continuous Glucose Monitoring System (CGMS) (Real-Time Continuous Glucose Monitoring System) |
| Specification | CGMS comprising: subcutaneously implanted glucose sensor, wireless transmitter, and handheld receiver/monitor. Sensor typically worn for 7-14 days. |
| Dosage Form | Medical Device — Continuous Glucose Monitoring System (electrochemical sensor-based) |
| Active Ingredient | N/A (medical device; glucose-oxidase based electrochemical sensor measuring interstitial fluid glucose) |
| Pharmacological Class | Medical Device — Diabetes Management / Glucose Monitoring (In Vitro Diagnostic / Self-Monitoring Blood Glucose Device Class) |
| Route of Administration | Subcutaneous sensor implantation (typically abdominal wall or upper arm) paired with wireless receiver. Sensor measures interstitial fluid glucose at regular intervals (e.g., every 1-5 minutes). |
| Storage | Store sensors in a cool, dry place (per label, typically 2°C-30°C). Protect from moisture and direct sunlight. Do not freeze. Receiver/monitor per device instructions. |
| Therapeutic group | Devices & Antisepsis — Devices & Antisepsis |
| Manufacturer | Sinophare Bio-technology Co., Ltd. (GMP, China) |
| Documentation supplied | COA, HPLC/GC data, stability data, dossier package |
The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Disposable Syringe Medical Sterile Plastic Syringe with Needle, Disposable 100ml Infusion Set With Burette For Children Tape-A Sterile IV Drip Set, Disposable Infusion IV Sets Sterile Medical Intravenous Drip Set, Medical Adhesive Tape Disposable Surgical Micropore Breathable Tape, Disposable Medical Mask, Disposable Fetal Head Suction Device Vacuum Obstetric Delivery Cup, Disposable Nitrile Gloves Powder Free Latex Free Medical Exam Gloves, Physiological Seawater Nasal Spray 60ml.
Quality Control, Pharmacopoeial Standards & Documentation
Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.
Continuous Glucose Monitoring System (CGMS) is released against the pharmacopoeial monograph named on your order (USP, EP, BP or CP). Where no monograph exists for the exact presentation, the specification is agreed with you in writing before manufacture and is attached to the certificate of analysis.
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
A typical release panel for this presentation covers:
- Testing for description and identification
- Testing for assay of the active substance
- Testing for related substances and impurities
- Testing for dissolution or release profile (solid oral forms)
- Testing for uniformity of dosage units
- Testing for water content and pH where applicable
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Packaging, Labelling & Export
- Pack size: CGMS kit containing: sensor(s), transmitter, receiver/monitor, applicator, charger, and accessories. Typically 1 or 3 sensors per kit.. Non-standard pack sizes can be quoted against your artwork.
- Storage: Store sensors in a cool, dry place (per label, typically 2°C-30°C). Protect from moisture and direct sunlight. Do not freeze. Receiver/monitor per device instructions..
- Shelf life: Per product labeling (typically 12-24 months for unopened sensors; device battery life per manufacturer specifications). Stability data for the marketed pack is included in the dossier.
- Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
- Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.
Registration, Dossier & Tender Support
Sinophare Bio-technology Co., Ltd. holds DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. That registration identifies the legal manufacturer on the certificate of analysis, the GMP certificate and the documents filed with your national medicines authority.
- CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
- Site Master File and GMP certificate for the manufacturing workshops.
- Method validation, stability protocol and the shelf-life justification for the marketed pack.
- Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
- Tender and framework documentation, including pre-qualification questionnaires and sample logistics.
This page describes Continuous Glucose Monitoring System (CGMS) as a product of the antiseptics and medical consumables referenced in WHO guidance family. A WHO or national listing is a supply-context fact, not an approval in your market; marketing authorisation remains specific to each country.
Frequently Asked Questions
What pack size is available for Continuous Glucose Monitoring System (CGMS)?
The reference pack is CGMS kit containing: sensor(s), transmitter, receiver/monitor, applicator, charger, and accessories. Typically 1 or 3 sensors per kit.. Non-standard blister, bottle and carton configurations are quoted against your artwork, matched to the stability data already held for the presentation.
What documentation comes with a shipment of Continuous Glucose Monitoring System (CGMS)?
Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: Per product labeling.
Does the batch documentation for Continuous Glucose Monitoring System (CGMS) support a registration filing?
Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: Per product labeling. The full CTD dossier and the authority assessment file are supplied as part of a registration order; routine shipments carry the COA and stability data only.
What chlorhexidine specifications do you supply?
Both the 2% chlorhexidine gluconate solution used as a general antiseptic and the 7.1% digluconate cord-care gel delivering 4% chlorhexidine specified in section 22.7 of the Model List. These are different products for different indications.
Why do you highlight the WHO chlorhexidine alert?
Because container confusion between chlorhexidine and eye preparations has caused more than 40 cases of serious eye injury including blindness. Selecting a visually distinct container is a WHO recommendation and we treat it as a specification, not an afterthought.
Related Devices & Antisepsis Products
- Disposable Syringe Medical Sterile Plastic Syringe with Needle
- Disposable 100ml Infusion Set With Burette For Children Tape-A Sterile IV Drip Set — 100ml
- Disposable Infusion IV Sets Sterile Medical Intravenous Drip Set
- Medical Adhesive Tape Disposable Surgical Micropore Breathable Tape
- Disposable Medical Mask
- Disposable Fetal Head Suction Device Vacuum Obstetric Delivery Cup
Browse the full Devices & Antisepsis range; all Medical devices; the complete product catalogue.
Request a Quotation for Continuous Glucose Monitoring System (CGMS)
Send the specification, pack size, quantity and destination market for Continuous Glucose Monitoring System (CGMS) and we will confirm availability, lead time and documentation. Tender quantities and registration samples are handled on the same quotation.
Sources & Regulatory Notes
- WHO — Chlorhexidine 7.1% digluconate: reports of serious eye injury (Information Notice, Aug 2020)
- WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- MSF Essential Drugs — Chlorhexidine 7.1% dermal gel
Reference information only. The published guidance summarised on this page is quoted for professional and regulatory-context purposes and does not constitute medical advice, a prescribing recommendation or a promotion of any product for a particular indication. Prescribing decisions must follow the approved product information and national treatment guidelines in the market of use.
