Packing condom at your own facility is illegal

Many clients plan to buy foiled condom in bulk from us, and then packing at their own workshop, we always inform our clients, you have to get the medical device production license, or it's illegal.

Which files you need to prepare when you want to apply the medical device production license, please check following requirement list, which is the standard requirements from China FDA department:

(1) The persons in charge of production, quality, and technology at an enterprise shall possess professional competence commensurate with the medical devices being manufactured, and shall be well-versed in national laws, regulations, and rules concerning the supervision and administration of medical devices, as well as relevant standards and technical requirements for product quality. The person in charge of quality shall not concurrently serve as the person in charge of production;
(2) The proportion of technical personnel within the enterprise—defined as those holding a professional title of "junior" level or above, or possessing an educational background of a specialized secondary school (technical secondary school) level or higher—shall be commensurate with the requirements of the products being manufactured;
(3) An enterprise shall possess production equipment, production and storage facilities, and an operating environment that are commensurate with the products being manufactured and the scale of production. Where an enterprise manufactures medical devices that require specific environmental conditions or specialized equipment, such conditions and equipment shall comply with national standards, industry standards, and other relevant national requirements;
(4) An enterprise shall establish a quality inspection department and possess quality inspection capabilities commensurate with the types of products manufactured and the scale of production;
(5) An enterprise shall maintain a collection of laws, regulations, rules, and relevant technical standards pertaining to the manufacture and business operations of medical devices.

Each country always has different rules of condom, please inquiry your authority before go ahead, such as USA is FDA, Nigeria is NAFDAC, South Africa is SABS. Before 2010, you can get the medical production license if you has a packing machine, but you had to own production line if you still want to get he production license, this increase the standard to has production license.