Regulatory Consulting Services
• Medical Device
• In vitro Diagnostics
• Cosmetics
• Pharmaceuticals
MEDICAL DEVICES
As medical device regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for RA professionals in the medical device and IVD industry. The idea is to give you short updates on regulatory topics that may be of interest to you.
Without manufacturing of medical device we can also sell products within India, they need to be in compliance with India’s minimal medical device regulations. India publishes a list of devices on the basis of the classification that require registration. The registration of these products is regulated under the provisions of the Drugs and Cosmetics Rules.
Concerned Department: Central Drugs Standard Control Organisation (CDSCO)
SERVICES
1. Registration of Medical Devices (Form-41)
2. Import License (Form-10)
3. Test License (Form-11)
Documents require-
• Apostilled Power of Attorney (Original)
• Notarized copy of valid Wholesale License or Manufacturing License of the Indian Agent
• Schedule DI & Undertaking duly filled, signed, stamped & dated with name & designation of the manufacturer/Indian agent.
• Schedule DII duly filled, signed, stamped & dated with name & designation of the manufacturer/Indian agent.
• Duly apostilled/notarized copy of Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of country of origin
• Duly apostilled/notarized copy of Free Sale Certificate Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, Canada, Japan, Australia.
• Certificate supporting quality management system(ISO:13485)
• Full quality Assurance Certificate/CE type examination Certificate/CE product quality assurance
• CE design Certificate
• Declaration of conformity
• Notarized Plant Master file
• Notarized Device Master file
• Post marketing surveillance along with the Recall and adverse event
IVDs (DIAGNOSTIC KITS)
An IVD Medical Device is defined as a device which, whether used alone or in combination, is intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use. It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures.
SERVICES
1. Registration of Critical Diagnostics (HIV, HCV, HBV, Blood Grouping Sera) (Form-41)
2. Import License of Critical Diagnostics (Form-10)
3. Test License of Critical Diagnostics (Form-11)
4. Performance Evaluation Report (PER) from NIB, Noida
5. Import License of Non-critical Diagnostics (Form-10)
6. Test License of Non-critical Diagnostics (Form-11)
7. Performance Evaluation Report of Semi-Critical Products from NABL Accredited Labs (Malaria, TB, Dengue, Chikunguniya, Typhoid, Syphilis, Cancer and Blood Glucose test strip)
Documents require-
• Apostilled Power of Attorney (Original) issued by the manufacturer to Indian agent
• Notarized copy of valid Wholesale License or Manufacturing License of the Indian Agent
• Schedule DI & Undertaking duly filled, signed, stamped & dated with name & designation of the manufacturer/Indian agent.
• Schedule DII duly filled, signed, stamped & dated with name & designation of the manufacturer/Indian agent.
• Duly apostilled/notarized copy of Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of country of origin
• Duly apostilled/notarized copy of Free Sale Certificate Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, Canada, Japan, Australia.
• Certificate supporting quality management system(ISO:13485)
• Full quality Assurance Certificate/CE type examination Certificate/CE product quality assurance
• CE design Certificate
• Declaration of conformity
• Performance Evaluation Report of Products (HIV, HCV, HBV & Blood grouping sera) from NIB, Noida for three consecutive batches.
• Notarized Plant Master file
• Notarized Device Master file
• Post marketing surveillance along with the Recall and adverse event
COSMETIC
Cosmetics are substances or products used to enhance or alter the appearance or fragrance of the body. Many cosmetics are designed for use of applying to the face and hair. They are generally mixtures of chemical compounds; some being derived from natural sources (such as coconut oil), and some being synthetics.[1] Common cosmetics include lipstick, mascara, eye shadow, foundation, rouge, skin cleansers and skin lotions, shampoo, hairstyling products (gel, hair spray, etc.), perfume and cologne. Cosmetics applied to the face to enhance its appearance are often called make-up or makeup.
SERVICES
Registration (Form 43)
Documents Require
• Power Of Attorney
• Duly filled, signed and sealed Schedule D-III by manufacturer or Indian agent along with undertaking (A. Particulars of Manufacturer and manufacturing premises, B. Undertaking to declare as per detail given in schedule D-III)
• Name of Ingredients in the Nomenclature of standard reference, along with percentage contend in the cosmetics.
• Specification and testing method for testing of cosmetics.
• Label
• Package inserts
• Authenticated copy of manufacturing licenses/registration/marketing authorization in respect of applied products issued by regulatory Authority from country of origin (In case there is no provision of manufacturing licenses/marketing authorization in country of origin, an undertaking for the same from the manufacturer is required to be submitted)
• Original Free Sale Certificate issued by National Regulatory Authority of Country of origin for the applied products. OR In case if it is not issued by National Regulatory Authority from the country of origin then from other competent Associations/ organizations duly authenticated from the Indian embassy of country of origin need to be submitted. (Free Sale Certificate from the country of Legal Manufacturer in addition to the Actual Manufacturer from the country of origin can be considered)
• Undertaking that the cosmetic products to be imported in to the country have not been tested on animals.
• Test report including result of Pb, As, Hg and microbiological test (Wherever applicable) / Undertaking from the manufacturer stating compliance of all raw materials/pigments used, heavy metals and hexachlorophene contents in products with Bureau of Indian Standards and Drugs & Cosmetic Rules, 1945
Pharmaceutical
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications. Pharmaceutical companies may deal in generic or brand medications. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
SERVICES
• Registration of Pharmaceutical (Form-41)
• Import License (Form-10)
Documents Require-
• Original Power of Attorney
• Copy of Whole sale License(20B/21C) or Manufacturing License of the Indian agent/Corporate office address
• Label
• legal undertaking from Indian agent providing the name, designation, signature telephone number, e-mail & fax of the authorized person responsible for the signing of documents Form 40, Power of Attorney & Form 9 for the registration & issue of Import License
• legal undertaking from manufacturer providing the name, designation, signature telephone number, e-mail & fax of the authorized person responsible for the signing of documents Form 40, Power of Attorney & Form 9 for the registration & issue of Import License.
• Schedule D (I) and Undertaking duly signed, dated and seal/stamped with name and designation of the authorized signatory of the manufacturer or his authorized Indian agent.
• Notarized Plant Master File
• Schedule D (II) and Undertaking duly signed, dated and seal/stamped with name and designation of the authorized signatory of the manufacturer or his authorized Indian agent.
• Notarized Drug Master File
• Manufacturing License/Product authorisation certificate
• GMP Certificate(Duly Apostilled/Notorised copy)
• COPP Certificate (Duly Apostilled/Notorised copy)
• FSC Certificate (Duly Apostilled/Notorised copy)
• Product Registration Certificate (SFDA), in case of China
• Certificate of suitability from EDQM