Ministry of Health, Bahrain
Link for RA:
GSO 1943/2016 for product safety and GSO 2528/2016 for claim
Who can register :
It is required to appoint an authorized representative and register it with the authority. The authorized representatives are the only party entitled to submit an application for registration
Data to be communicated :
- Original letter of appointment, stamped and signed by the manufacturer or distributor for the sole agency in Bahrain
- Copy of Commercial Registration
- Imported cosmetic products license request form includes the name of the manufacturer, country of origin and the names of products to be imported.
- Good Manufacture Practice Certificate issued and rectified by the governmental health authority
- Free Sale Certificate Issued and rectified by governmental health authority and Bahrain Embassy in the country of origin, includes the name, address of the manufacturer and the name of the products to be imported.
- The certificate of the composition of each product shows the percentages of the ingredients and their functions, stamped and signed by the manufacturer
- Certificate of analysis of the products from an accredited laboratory
- If the product contains active ingredients or claims to cause physical changes to the body, documents and clinical studies must be submitted to prove the efficacy according to the claims mentioned, safety assessment, the toxicological profile of the ingredients, side effects, stability study, period of validity, storage condition, quality of the packaging and method of analysis according to what is stated in the certificate of analysis.
- Samples of the products in their original packaging (non-refundable) with the outer and inner label or insert leaflet stating the essential information in English and Arabic languages
- The certificate proves that the product is free from Bovine spongiform encephalopathy
- Halal Certificate
- If a product contains herbal materials, a scientific reference of their safety, validity, use and effectiveness is required.
- If a product contains active ingredients or claims, the following should be submitted:
- Safety assessment
- Toxicological profile of the ingredients
- Undesirable effects
- Stability study
- Validity period, storage conditions and packaging type
- Method of analysis
Bahrain does not require any Notification.
The registration procedure determines whether or not a product meets the safety and performance requirements outlined in applicable legislation and standards.
- It is necessary to appoint and register an authorised representative with authority. The approved representatives are the only ones who can submit a registration application.
- Before filing an application, all medical devices should be assigned a correct class based on the risk-based classification.
- Following registration, the official authority’s website will make information about the registered device and the applicable authorised representative available.
- Only devices that have been legally registered for placement on the national market are allowed to be purchased by healthcare facilities.
- Importation and NHRA registration are two distinct processes that should be handled separately.
- There are no registration costs as of July 2019; they will be announced later.
- The license holder must submit a renewal request in advance (nine months before the license expiration date).
- All medical devices to be placed on the national market should have a quality assurance certificate issued by a notified body.
Timeframe and fees:
It is crucial to highlight that the labels’ designs, images, and phrases must be consistent with Islamic traditions and societal values, that specific elements of the label must be translated into Arabic, and that claims must be valid.
Products must meet certain criteria, including being entirely free of pork and its derivatives, being safe for human health under normal and reasonably foreseeable conditions of use, being stable and having properties that impact safety, efficacy, and quality that does not change during their shelf life, and being free of filthy or decomposed substances.