Misconception of regulatory classification of medical products

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Registration of a medical product starts with an official classification  which will determine the documentary requirements, timelines, and fees. Today we are going to share a few misconceptions and the approach to classify a product correctly.

Misconception

1. We assume that the classification in the country of origin will be the classification in the country to be exported . E.g A product that is a classified as an OTC product in the country of origin might be deemed as a medical device in the country where it is exported to.
2. We did not check the definition of a specific category of the product based on local regulations. We assume the definition based on what we understand in common regarding a specific category of product. E.g a medical device should only treat, diagnose, and prevent a medical condition through “mechanical action” but not by immunochemical or pharmacological means.
3. Marketing claims which might not be suited for the specific category of the product such as health supplement that might overclaim its function without referencing to established pharmacopeia or proven efficacy through human studies such as a clinical trial.

Approach to classification of a product

1. Active ingredient- Is this a Poison or controlled substance under the Pharmaceutical Act? What is the strength or allowable limit of a substance that might put it at risk of being categorized as a higher risk product?
2. Mode of action- Does the principle of action qualify it as more” therapeutic” in a pharmaceutical way or relieving or replacement of a physiological process like a medical device?
3. Indications- Are the indications backed by clinical studies or literature papers? Does the indications allow you to classify as a lower category then what it actually is?
4. Matching the definition in regulatory guidelines – Considering the above elements, do a check against the definition to see whether it meets the classification that you think your medical product would fit.

Common definitions based on Health Product Act  that might be useful for classification of a product:

Medical Device : any instrument, apparatus, implement, machine, appliance, implant, reagent for in‑vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of

• diagnosis, prevention, monitoring, treatment or alleviation of disease
• diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury
• investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;
• supporting or sustaining life;
• control of conception
• disinfection of medical devices
• providing information by means of in‑vitro examination of specimens derived from the human body, for medical or diagnostic purposes

Therapeutic product  means any substance that is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes: for preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof;

• for investigating, modifying or replacing any physiological process;
• for influencing, controlling or preventing conception
• for inducing anaesthesia;

has as a constituent any of the following active ingredients:

(i)any chemical or botanical element, naturally‑occurring chemical or botanical material, or chemical product obtained by chemical change or synthesis;

 (ii) any metabolite from a micro‑organism;

 (iii)any macromolecule extracted from an organism;

 (iv)any substance derived from a biological system, including any of the following:

• a whole cell or micro‑organism, such as a whole virus or bacterium used as a vaccine;
• a part of a micro‑organism, such as a sub‑unit vaccine;
• a plasma‑derived product;
• a biotechnology‑derived substance, such as a protein or polypeptide, or a recombinant vaccine for a preventive purpose;

 exerts an inherent effect either pharmacologically, chemically or by other physiological means, leading to its use for a therapeutic, preventive, palliative or diagnostic purpose.

Cosmetic product means any substance or preparation that is intended by its manufacturer to be placed in contact with the various external parts of the human body or with the teeth or the mucous membranes of the oral cavity, with a view exclusively or mainly to

a)cleaning them;

(b)perfuming them;

(c)changing their appearance;

(d)correcting body odours;

(e)protecting them; or

(f)keeping them in good condition.

Health Supplement is used to supplement a diet and to support or maintain, enhance and improve the healthy functions of the human body. It cannot be an injectable or a preparation that needs to be sterile, such as injections and eyedrops. It cannot be an item of a meal or diet.

Chinese proprietary medicine means any medicinal product used in the system of therapeutics according to the traditional Chinese method, that is to say, any medicinal product —

1. which has been manufactured into a finished product;
2. which contains one or more active substances derived wholly from any plant, animal or mineral, or any combination thereof;
3. which is, or all of the active substances of which are, described in the current edition of “A Dictionary of Chinese Pharmacy” «中药大辞典» or “The Chinese Herbal Medicine Materia Medica” «本草纲目»;
4. which does not contain as an active substance any chemically‑defined isolated constituent of any plant, animal or mineral, or any combination thereof; and
5. which is not intended to be administered by injection into a human body;

Homoeopathic medicine means any substance used in the system of therapeutics in which a disease is treated by the use of minute amounts of one or more substances which, in their undiluted forms, are capable of producing in healthy humans symptoms similar to those of the disease being treated;

Quasi‑medicinal product means:

1. any anti‑dandruff preparation;
2. any medicated cosmetic product for the treatment of pimples or acne, except any preparation containing etretinate or 13‑cis‑retinoic acid;
3. any medicated soap;
4. any sweet for relieving coughs or throat irritations;
5. any medicated plaster;
6. any sunscreen or suntan preparation;
7. any medicated beverage;
8. any vitamin or nutritional preparation from any natural source; or
9. any medicated toothpaste;

 

We hope that the above article has been useful for you. If you do have a borderline product that might require a second opinion to justify your classification. Feel free to engage with us. Best of luck, share this with peers who might need them.

 

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