Interview with Dr. Salim Ahmed Bobhair

Theresa Ashford of AmeeraHealth has interviewed the General Manager of Five Dimensions for Pharmaceutical & Medical Device Consulting – Dr. Salim Ahmed Babhair, specifically focusing on the regulatory requirements which – following the 2007 ruling – are now in force in KSA.

Riyadh, Saudi Arabia. September 2013.

Q. You have been involved in the healthcare industry in different capacities for more than 30 years. What changes have you seen in the medical industry during that time?

A. Saudi Arabia has undergone an enormous transformation over the years. Population demographics have changed, thereby diversifying the need for healthcare facilities in order to cater for each demographic segment. The Government has undertaken an ambitious plan to expand the provision of healthcare facilities and services. Healthcare insurance becomes more structured with each passing year and the private healthcare sector is also developing at quite at a pace.

These macro level and policy changes have also led to increased regulations in the pharmaceuticals, medical devices & equipment market. In order to ensure that only quality products can enter Saudi Arabia, the Saudi Food & Drug Authority (SFDA) was formed in order to act as a gate keeper. This significant development has greatly changed the way medical products are registered and marketed within the market.

Q. What has been the impact of the new regulations on imported products into KSA?

A. The regulations applied to imports are helping to standardise products and ensure their safety and quality.

Q. How is the SFDA regulating the medical device sector?

A. The SFDA requires any foreign manufacturer to have an Authorized Representative in the country, which can represent the foreign company in all matters relating to SFDA procedures. These can include – but is not restricted to – product registration, product recall, field safety actions and coordinating with the SFDA on matters relating to ports market surveillance and vigilance

Q. How will the medical device & equipment regulations help develop the commercial sector?

A. We understand that these regulations will ensure that all medical devices and equipment are approved for marketing and sales within Saudi Arabia, thereby fulfilling the necessary usage and safety requirements. From time to time issues may arise with the medical devices and equipment due to reasons which only require some – often quite small – corrective measures. By introducing the tracking of products timely corrective measures can be taken, thereby ensuring patients safety. This also helps maintain device credibility within the market.

Q. What benefits might a manufacturer get by appointing a consulting office as its Authorized Representative even though they may already have a distributor?

A. The SFDA’s mandate is to focus only on regulatory, safety and quality matters. For this they only requite a single local entity or individual to have a mandate from the manufacturer to interact with the SFDA on these activities. It could happen that a manufacturer has multiple distributors covering different product lines. Should this be the case, it would be viable to interact with a specialist consulting office offering regulatory services.

With increased competition and short product life cycles it is critical to shorten the registration time in order to launch products at the earliest opportunity. A professional and dedicated regulatory service can greatly help to reduce this lead time.

By appointing an entity other than its distributor as its Authorized Representative, a manufacturer can also keep better control of the product registrations, e.g. should for whatever reason there be a switch over from one distributor to another, the product registrations would not be affected and the manufacturer would remain in control via its Authorized Representative.

Q. What business segments your services cover?

A. Our services remit covers pharmaceuticals, herbal drugs, cosmetics, dietary supplements, cosmetics, medical devices, IVDs and medical equipment.

Q. What is the scope of your activities?

A. Our team comprises more than 60 years of accumulative experience in pharmaceuticals and medical devices.

With Pharmaceuticals our services include manufacturing facilities design, pre-inspection GMP audits, pharmacovigilance system implementation, bioequivalence and clinical studies protocol design and evaluation, registration dossiers and drug master files (DMF) compilations, registration assistance and consultation contracts. We cover registration activities both in the SFDA and centralised registration in the Riyadh-based Gulf Cooperation Council Health Executive Board.

With medical devices and equipment our services include legal representation of the manufacturers within the scope as determined by the SFDA which includes product registration, marketing authorisations, post-marketing vigilance activities etc.

In addition we assist manufacturers to pre qualify the manufacturing facilities and their products for different centralised GCC tenders e.g. spine & orthopaedics, rehabilitation, cardiovascular surgery, dental, diagnostics, pharmaceuticals, renal dialysis etc.

Q. Will you be attending this year’s Medica?

A. A representative from the company will be visiting the show.

Q. Is there anything else you would like to add to enable UK readers to gain a further insight into your company and ethos?

A. Our company motto is to guide the manufacturers to complete the regulatory requirements as per requirements within the desirable time period in order to introduce their products in the market at the earliest opportunity. We also assist manufacturers in managing a good control over their registrations thereby, as already explained, ensuring that registrations remain intact in the case of any switch over of local commercial partners.

Although CE & MHRA approvals are acceptable in Saudi Arabia, manufacturers still need to complete the SFDA requirements in order to register and market their products.