Commercializing your product through regulatory classification

Healthcare industry remains to be one of the most regulated among all businesses. So how do small companies remain competitive in this regulated world? Today we will discuss about ways to maximize your product value through regulations.

We need to look closely at each category of classification: Medical Device, Drug Product, Cosmetics and supplements.

A medical device is a tool ( instrument, machine, diagnostic reagent, software and etc) that is intended to be used for diagnosis, prevention, monitoring and treatment of diseases.Usually a medical device would require a risk classification and grouping classification based on the intended use as well as the principle mode of operation. Class A(Class I /Class 1) Low risk device. Class B( Class IIa/Class 2 ) low-medium risk device. Class C (Class IIb/Class 2) moderate-high risk device. Class D (high risk/Class 3) high risk products. The technical requirements for a dossier in ASEAN would be a CSDT format which will consists of the following standard documentation such as but not limited to : Essential Principle Checklist, QMS certification(ISO 13485), Instructions for Use, Clinical and Non-clinical overview, and Risk Management.

Pros of registration as a medical device: Able to sell at higher price . Can open up more towards both the prescription and consumer market. Being innovative and unique allows you to stand out amongst competitor. Shorter registration lead time. Lower compliance cost. Sell a lot on consumable, technical servicing and parts. More route to open up for market trial before committing to registration.

Cons as a medical device: Small volume. Needs longer time to build a brand and requires heavy marketing. Invest in setting up a QMS which can be quite tedious for small company.

An example of such product is a vaginal pessary product ( med device/ cosmetic) . The proposed claim would be to maintain the healthy pH of the vaginal and also to prevent vaginitis. Depending on the market ‘s prevalence in the disease area, it would be better to market the product  as a medical device first as the gynecologist would be able to build the brand for you through prescription and educating the population on the practice. If the awareness of the condition is high, it would be better to market this as cosmetic to appeal to mass market with reduced claims.

A drug product is a chemical/ biological entity that is presented in various dosage form to treat and prevent of disease. Drugs are classified according to their status as a prescription(Px/POM) , pharmacy(Rx/OTC) and a general sales list( products that does not require any professional advice).  The technical requirement of a drug is much more extensive and typically would include but not limited to formulation studies, pharmaceutical development, manufacturing processes and controls, process validation studies, stability studies, bioequivalence studies, clinical and non clinical studies.

Pros of registration as a drug:  Claims are backed by established human studies. Able to sell at a higher volume compared to other products . Marketing is not as extensive in terms of cost wise for well-established drug profile.

Cons of registration as a drug: requires a lot of clinical data  and studies. Long registration time and cost. Need to compete a lot on relationship with healthcare institutions and   good supply practice ( able to meet the demand of the clinic).

One such example is a intraarticular injection (med device/ drug). The  intended use of an intrarticular injection : to replace the synovial fluid between the joints in osteoarthritis and rheumatoid arthritis. Active ingredient is a high molecular weight hyaluronic acid. However, some companies would prefer to register it as a drug product as it will be able to increase the prescription value for a doctor. Usually MNC follow this route and they will be established as a innovator in this area.

 Smaller companies would register it as a medical device as it has a shorter lead time to bring in the products. It also creates branding awareness by being the first few products to be launched.

A supplement consists of a standalone or combination of vitamins, minerals and extracts which is used to support a physiological function of the body.Often the claims are based on general usage of the vitamins, minerals or extracted clinical papers. Technical requirements are usually the ingredient listing, packaging, manufacturing processes as well as supporting evidence of clinical claims.

Pros of registration as a supplement: Registration lead time might be shorter and registration requirements are not as extensive compared to the rest of the products. The claims are essentially based on well-established studies about the product as essential vitamins and minerals to support and sustain physiological functions.

Cons of registration as a supplement : Limited medical claims. Have to check on the maximum and minimum and restricted ingredients that can be registered in the country . Similar competitors. Heavy marketing.

Let’s take a example of a food supplement which is intended to maintain good digestive system ( supplement/drug) . Such supplement is usually prevalence in the market so its better to register a higher category to give an edge that the product has clinical backings to it hence this will build your brand at a higher level than the rest of the competitors.  Will increase consumer confidence.

 A cosmetic product means any substance or preparation intended by its manufacturer to be placed in contact with the various external parts of the human body such as the skin epidermis, hair, nails, lips and external genital organs or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, correcting body odours, protecting them or keeping them in good condition. (taken from ASEAN Consumer Information Handbook on Cosmetic Product). Cosmetics products are categorized mainly as low risk or high risk (applied around the eye area or mouth area). The technical requirements would usually be a product information file consisting of the formulation, manufacturing process, relevant certification, and packaging.

Pros of registration as a cosmetic product: shorter registration lead time and technical requirements. Cost is lower to bring in the product.

Cons of registration as a cosmetic product: Heavy marketing and brand building.  Short product cycle. Many competitors.

Let’s take for example a sunblock ( cosmetic / medical device)that comes with a high SPF which is claimed to prevent the formation of melatonin or control the production of melatonin . It would better to register as  medical device since you would be able to use the prescription market to give you a higher brand value.

Regulatory classification can definitely put your product at an edge over your competitor if you are able to first evaluate and understand the intended market audience,the awareness of the market on the condition and how you want to position your product in the long run . By using the above strategy of categorization as well as the analysis of  the pros and cons you are able to better align your product with the  market demands and manage your product life cycle better.

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