I.Basic Overview of Pakistan

1. Due to the poor health condition of Pakistani citizens, the poor natural environment and the lack of public health knowledge and other factors, the demand for pharmaceuticals in Pakistan is robust and the consumption of anti-inflammatory drugs and painkillers increases dramatically during the rainy season when mosquitoes and insects are breeding. Furthermore, as the world's sixth most populous country, Pakistan's national population reaches 210 million people, with a recent population growth rate of 1.9% per year. These factors contribute to making Pakistan one of the most promising pharmaceutical consumption markets.

2. Pakistan has a significant demand for healthcare services and medical devices, particularly in the rapidly growing private healthcare market. Healthcare providers in Pakistan include the government, non-governmental organizations, and the private sector. As of the fiscal year ending in June 2021, the Government of Pakistan (GOP) spent approximately $785 million on healthcare.

3. With the progress of the China-Pakistan Economic Corridor (CPEC) construction, many Chinese pharmaceutical companies have entered the Pakistani market. In this context, traditional Chinese medicine theories are gradually gaining recognition in Pakistan, and consumer acceptance of Chinese herbal medicine is increasing. At the same time, Chinese medical devices are often more competitively priced and cost-effective than other competitors, which makes Chinese products more competitive in Pakistan medical device market. Chinese manufacturers offer a comprehensive selection of medical devices, whether it is diagnostic, imaging, and monitoring devices or surgical instruments, or disposable consumables.

4. Due to GOP plans to expand its healthcare network, Pakistan has witnessed a surge in demand for diagnostic and laboratory equipment, the number of hospitals, dispensaries, and medical units will increase and the market demand for the following equipment is expected to grow:

Respirators (HS 9019), monitors, ventilators and related instruments, personal protective equipment, dental and veterinary instruments and apparatus (HS 9018), orthopedic appliances, hearing aids (HS 9021), X-ray and radiography/radiotherapy equipment (HS 9022), used and second-hand X-ray machines, dialysis machines, anesthesia devices, health IT/telemedicine/electronic health.

II. Regulatory Authorities in Pakistan:

In Pakistan, medical devices require certification by the Drug Regulatory Authority of Pakistan (DRAP) for legal sale and use. All medical equipment is regulated by the Medical Devices and and Pharmaceutical Cosmetics of the DRAP.

III. Classification of Medical Devices in Pakistan:

Class A - Simple wound dressing lint, needle-free syringes, urine collection bottles, examination gloves-low risk.

Class B - Non-medicated gauze dressings, transfusion tube, urinary catheters - Moderate-low risk.

Class C - Chronic ulcer wound dressings, severe burn dressings, blood bags - Moderate-high risk.

Class D - Angioplasty balloon catheters and related guidewires, specialized disposable cardiovascular surgical instruments, breast implants - High risk.

IV. Pakistan Registration Points

1. Importers/Distributors and independently certified local authorized representatives can act as certificate holders. As a certificate holder for medical device registration, they must have a license for importing and distributing medical devices in Pakistan. The certificate holder is responsible for managing post-market surveillance activities and assisting clients with the import process.

2. Dependence and Exemption Mechanism: According to applicable regulatory requirements, if the reviewed medical device has already been registered with more stringent requirements by a foreign regulatory authority, the Medical Device Board (MDB) will issue the corresponding certificate based on the registration. Furthermore, the rules specify the requirements that medical devices outsourced, including registrations/approvals granted by foreign regulatory authorities. For the purposes of this clause, trusted jurisdictions include the United States, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom. The reliance mechanism can also be applicable to inspections and exemptions related to it.

(1) Class A:

Stakeholders should submit the following documents:

Relevant certificates (ISO 13485, duly notarized).

Notarized authorization from the original medical device manufacturer.

Duly notarized Free Sale Certificates from the country of origin.

Duly notarized Declaration of Conformity from the foreign manufacturer.

Duly notarized Product or Full Quality Assurance Certificate (CE Marking Certificate) issued by a Conformity Assessment Body (CAB)

(2) Class B, C, or D:

The range of documents required when applying for an import license for higher-class medical devices. In addition to the ISO 13485 certificate and authorization letter issued by the medical device manufacturer mentioned above, stakeholders must also submit:

Duly notarized Free Sale Certificates and Declarations of Conformity from the country of origin.

Full Quality Assurance Certificate (CE Mark Certificate) from a Conformity Assessment Body (CAB).

(3) Class D:

Provide a Design Review Certificate.

Submit Notarized Free Sale Certificates from any of the reference countries, including the United States, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom.

Include Notarized Free Sale Certificates from the country of origin along with WHO Prequalification status.

3. In terms of the compliance assessment procedure:

Prepare a Declaration of Conformity (DoC).

Establish a Quality Management System (QMS) that meets ISO 13485 certification.

Create a Common Submission Dossier Template (CSDT) with details about the medical device's classification and description, preclinical study data, clinical evidence, information regarding whether the device is novel or poses hazards, and evidence of compliance. The CSDT should be in English.

The Medical Device Board (MDB) will review the dossier and approve the submission of hard copies of technical documents to the authority when necessary.